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2004年—至今 全世界批准上市药品/适应症时间目录表
Recently Approved Drugs/Indications

02/22/2010

FDA Approves Once-Daily Pramipexole for Early Parkinson's Disease

02/22/2010

FDA Approves New Meningococcal Disease Vaccine

02/18/2010

FDA Approves Rituximab to Treat Chronic Lymphocytic Leukaemia

02/17/2010

Health Canada Approves Concentrated Version of Alpha1-Proteinase Inhibitor

02/17/2010

NICE Recommends Liraglutide for Diabetes Triple Therapy

02/11/2010

FDA Approves Olmesartan Medoxomil for Hypertension in Children, Adolescents

02/09/2010

Health Canada Approves HPV Vaccine, Types 16 and 18

02/09/2010

Health Canada Approves Darunavir for Children, Adolescents With HIV

02/08/2010

Rosuvastatin Approved for US Adults With No Clinically Evident Cardiovascular Disease

02/03/2010

US FDA Approves First Nonsurgical Treatment for Adult Dupuytren's Contracture

02/01/2010

FDA Approves Lapatinib/Letrozole for Hormone-Positive, HER2-Positive Advanced Breast Cancer

02/01/2010

FDA Approves Once-Daily Lamotrigine XR for Primary Generalised Tonic-Clonic Seizures

01/29/2010

FDA Warns of Serious Liver Disorder Associated With Use of Didanosine

01/26/2010

FDA Approves Once-Daily Liraglutide Injection for Type 2 Diabetes

01/24/2010

FDA Approves Dalfampridine to Improve Walking in Adults With MS

01/21/2010

FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients

01/21/2010

FDA's Safety Review of Sibutramine Warrants New Contraindication Label

01/14/2010

Health Canada Approves Budesonide/Formoterol Dry Powder Inhaler for COPD

01/13/2010

FDA Approves Plasma Replacement Therapy for von Willebrand Disease

01/11/2010

FDA Approves Tocilizumab for Rheumatoid Arthritis

01/05/2010

Health Canada Approves Imiquimod Cream for Actinic Keratosis

12/23/2009

FDA Approves New Influenza Vaccine Designed Specifically for Older Adults

12/23/2009

FDA's Ongoing Safety Review Shows No Link Between Ezetimibe/Simvastatin, Cancer Risk

12/22/2009

Health Canada Approves 13-Valent Pneumococcal Vaccine

12/18/2009

FDA Approves Tiotropium Bromide Inhalation Powder for Reducing COPD Exacerbation

12/15/2009

Four Lots of H1N1 Vaccine Recalled, Revaccination Not Required

12/14/2009

FDA Approves Long-Acting Olanzapine Intramuscular Injection for Schizophrenia

12/08/2009

FDA Interim Recommendations on Potential Excess Radiation Exposure During CT Scans

12/02/2009

FDA Approves Low-Dose Local Oestrogen Therapy for the Treatment of Atrophic Vaginitis Due to Menopause

12/02/2009

FDA Approves Ecallantide for Treatment of Acute Attacks of Hereditary Angio-Oedema in Patients 16 Years and Older

11/30/2009

FDA Approves Agriflu Seasonal Influenza Vaccine

11/23/2009

FDA Investigates Risk of Cardiovascular Events in Patients Using Sibutramine

11/20/2009

FDA Approves Aripiprazole to Treat Irritability Associated With Autistic Disorder

11/20/2009

FDA Approves Ziprasidone for Adjunctive Maintenance Treatment of Bipolar Disorder

11/19/2009

Lubiprostone Approved in Switzerland for Chronic Idiopathic Constipation

11/17/2009

FDA: Avoid Coadministration of Clopidogrel and Omeprazole, Esomeprazole

11/16/2009

FDA Approves Capsaicin 8% Patch for Treatment of Postherpetic Neuralgia

11/13/2009

FDA Approves Tranexamic Acid Tablets to Treat Menorrhagia

11/13/2009

Health Canada Approves Unadjuvanted H1N1 Vaccine

11/12/2009

FDA Approves H1N1 Vaccines for Children as Young as 6 Months Old

11/06/2009

FDA Approves Romidepsin Injection for Previously Treated T-Cell Lymphoma

11/02/2009

FDA Approves Exenatide as First-Line Treatment for Type 2 Diabetes

10/27/2009

Rilonacept Approved in the EU for Cryopyrin-Associated Periodic Syndromes

10/27/2009

FDA Grants Accelerated Approval to Ofatumumab for Refractory Chronic Lymphocytic Leukaemia

10/26/2009

FDA Authorises Emergency Use of Intravenous Peramivir for Certain Hospitalised Patients With H1N1 Influenza

10/19/2009

FDA Approves Pazopanib for Advanced Renal Cell Carcinoma

10/19/2009

FDA Approves New Seasonal Influenza Vaccine for Paediatric Use

10/19/2009

FDA Approves Telmisartan, Amlodipine Combination Tablets for Hypertension

10/19/2009

FDA Approves Telmisartan to Reduce Risk of Cardiovascular Events in High-Risk Patients

10/19/2009

FDA Approves Rasburicase for Management of Hyperuricemia in Patients With Haematologic Malignancies

10/19/2009

FDA Approves HPV Recombinant Vaccine, Types 16 and 18

10/16/2009

FDA Approves HPV Vaccine for Prevention of Genital Warts in Boys, Young Men

10/12/2009

Zanamivir Dry Powder Should Not Be Delivered by Nebuliser, FDA Warns

10/12/2009

FDA Approves a C1-Esterase Inhibitor for Abdominal Attacks, Facial Swelling Associated With HAE

10/09/2009

FDA Conducting Safety Investigation of CT Brain Perfusion Scans

10/07/2009

FDA Approves Colesevelam HCl for Children With Familial Hypercholesterolemia

10/01/2009

FDA Approves Levonorgestrel IUD to Treat Heavy Menstrual Bleeding

10/01/2009

Health Canada Approves Telavancin for Complicated Skin, Skin Structure Infections

10/01/2009

New USP Standards for Heparin Products Will Result in Decreased Potency

09/25/2009

FDA Conducting a Safety Review of Deferasirox Due to Reported Adverse Events

09/25/2009

FDA Approves Ustekinumab for Moderate to Severe Psoriasis

09/25/2009

FDA Recommends Labelling Change for Sitagliptin to Include Risk of Pancreatitis

09/25/2009

FDA Approves Pralatrexate Injection for Relapsed, Refractory Peripheral T-Cell Lymphoma

09/25/2009

FDA Warns of Potential Dosing Errors With Oseltamivir

09/22/2009

FDA Continues to Receive Reports of PML in Patients Receiving Natalizumab

09/17/2009

FDA Approves Single Pill Combination of Valsartan, Aliskiren for Hypertension

09/16/2009

FDA Requires Boxed Warning for Promethazine Hydrochloride Injection

09/16/2009

FDA Approves Ganciclovir Ophthalmic Gel for Herpetic Keratitis

09/15/2009

FDA Approves Four Vaccines for the 2009 Influenza A(H1N1) Virus

09/14/2009

Once-Daily Lopinavir/Ritonavir Tablet Approved in EU for Treatment-Naïve HIV Patients

09/14/2009

FDA Approves Telavancin for Complicated Skin and Skin Structure Infections

09/09/2009

FDA Approves Bepotastine Besilate Solution for Ocular Itching Associated With Allergies

09/08/2009

FDA Approves Metoclopramide Rapid Dissolving Tablets for Diabetic Gastroparesis, GERD

09/04/2009

FDA Approves Ibritumomab Tiuxetanton as First-Line Therapy for Non-Hodgkin's Lymphoma

09/03/2009

Rituximab Approved in Europe for Patients With Previously-Treated CLL

09/03/2009

FDA Approves Once-Daily Guanfacine XR for ADHD in Children, Adolescents

08/31/2009

FDA Approves Valganciclovir Hydrochloride to Prevent CMV in Paediatric Transplant Recipients

08/28/2009

FDA Approves Pancrelipase for Children, Adults With Exocrine Pancreatic Insufficiency

08/25/2009

FDA Approves Levocetirizine Dihydrochloride for Paediatric Nasal Allergies

08/24/2009

FDA Investigates Reports of Liver Damage From Weight Loss Drugs

08/21/2009

FDA Approves Vigabatrin for Infantile Spasms

08/17/2009

Rituximab Plus Chemotherapy Approved in Canada for Previously Untreated CLL

08/17/2009

FDA Approves Treatment Protocol for Use of Glucocerebrosidase

08/14/2009

FDA Reports Cases of Pure Red Cell Aplasia in Patients Treated With Mycophenolate Mofetil

08/14/2009

Psychotropic Drug Asenapine Receives Simultaneous Initial FDA Approval for Schizophrenia and Bipolar I Disorder

08/13/2009

FDA Approves Tamper-Proof Long-Acting Opioid for Management of Moderate to Severe Chronic Pain

08/06/2009

EU Approves Everolimus for Second-Line Treatment of Advanced Kidney Cancer

08/05/2009

Plerixa Injection Approved in EU to Enhance Mobilisation of Stem Cells

08/03/2009

FDA Approves Pitavastatin for Primary Hypercholesterolaemia, Combined Dyslipidaemia

08/03/2009

FDA Approves Bevacizumab Plus Interferon Alfa for Metastatic Renal Cell Carcinoma

07/31/2009

Extended-Release Injectable Paliperidone Approved in the US for Schizophrenia

07/31/2009

FDA Approves First Antipsychotic for Schizoaffective Disorder

07/31/2009

FDA Approves Saxagliptin for Type 2 Diabetes

07/30/2009

FDA Approves Treprostinil Inhalation Solution for Pulmonary Arterial Hypertension

07/29/2009

EU Approves Bevacizumab Plus Docetaxel for First-Line Metastatic Breast Cancer Treatment

07/23/2009

FDA Approves Expanded Use of Teriparatide (rDNA Origin) Injection to Treat Glucocorticoid-Induced Osteoporosis

07/23/2009

FDA Approves Preservative-Free Ketorolac Formulation Ophthalmic Solution for Treatment of Pain, Inflammation Following Cataract Surgery

07/23/2009

Increased Risk of Myocardial Infarction With Fosamprenavir

07/21/2009

FDA Approves Aliskiren and Hydrochlorothiazide Combination Tablet for Patients Unlikely to Achieve Blood Pressure Goals With Single Agent

07/20/2009

FDA Approves Vaccine for 2009-2010 Seasonal Influenza

07/16/2009

FDA: Ongoing Omalizumab Study Shows Increased Number of Cardiovascular Events

07/16/2009

FDA Approves Fentanyl Buccal Soluble Film for Breakthrough Pain

07/14/2009

FDA Requires Labeling Changes for Immunosuppressant Drugs

07/10/2009

FDA Approves Prasugrel to Reduce the Risk of MI During, After Angioplasty

07/09/2009

Mometasone Furoate Dry Powder Inhaler Approved in Japan for Bronchial Asthma

07/09/2009

Mirtazapine Approved in Japan for Major Depressive Disorder

07/07/2009

FDA Takes Actions on Pain Medications Containing Propoxyphene

07/07/2009

Tacrolimus Approved for Refractory Ulcerative Colitis in Japan

07/06/2009

FDA Approves Pemetrexed as Maintenance Therapy for Advanced Lung Cancer

07/02/2009

FDA Panel Recommends Withdrawal of Acetaminophen-Containing Narcotics

07/02/2009

FDA Approves Dronedarone for Atrial Fibrillation or Atrial Flutter

07/01/2009

FDA: Boxed Warning Required for Varenicline, Buproprion Due to Risk of Suicidal Behaviour

07/01/2009

Gefitinib Approved in EU for Locally Advanced, Metastatic NSCLC

06/30/2009

FDA Approves Ferumoxytol for Iron Deficiency Anaemia in Patients With CKD

06/29/2009

Protein-Bound Paclitaxel Suspension Approved in Quebec for Metastatic Breast Cancer

06/26/2009

Once-Yearly Zoledronic Acid Approved in EU for Glucocorticoid-Induced Osteoporosis

06/25/2009

EMEA Recommends Withdrawal of Dextropropoxyphene-Containing Medicines

06/22/2009

FDA Approves Diclofenac Potassium Oral Solution for Migraine

06/18/2009

FDA Approves Canakinumab for Cryopyrin-Associated Periodic Syndrome

06/18/2009

FDA Approves Dexamethasone Intravitreal Implant for Macular Oedema

06/16/2009

Loss of Sense of Smell With Intranasal Cold Remedies Containing Zinc

06/15/2009

Oseltamivir, Zanamivir for Influenza A(H1N1) Appear Safe for Pregnant Women

06/15/2009

FDA Unable to Conclude Risk/Benefit Profile of Stimulant Drugs in Children With ADHD

06/14/2009

FDA Issues Public Health Advisory Regarding Insulin Detemir

06/12/2009

FDA Requests Labelling Change for Asthma Medications

06/12/2009

Sevelamer Carbonate Approved in EU for Patients With Chronic Kidney Disease

06/11/2009

FDA: Increased Mortality in Stable Liver Transplant Recipients Taking Sirolimus

06/04/2009

Use of Mycophenolate Mofetil Associated With Pure Red Cell Aplasia, Warns Health Canada

06/03/2009

FDA: Propylthiouracil Increases Risk of Serious Liver Injury, Death

06/01/2009

FDA Warnings About Antidepressants Associated With Changes in Diagnosis, Treatment

06/01/2009

FDA Approves Once-Daily Extended Release Lamotrigine for Epilepsy

06/01/2009

FDA Approves Bi-Yearly Zoledronic Acid Injection to Prevent Osteoporosis in Postmenopausal Women

05/31/2009

Lapatinib Ditosylate Plus Capecitabine Approved for Patients With HER2+ Breast Cancer in Canada

05/29/2009

FDA Approves Besifloxacin to Treat Bacterial Conjunctivitis

05/28/2009

FDA Approves Tacrolimus Plus Mycophenolate Mofetil for Prevention of Kidney Rejection in Transplant Recipients

05/26/2009

FDA Approves Dasatinib for CML in Patients Resistant, Intolerant to Prior Therapies

05/26/2009

FDA Approves Tadalafil Tablets for Pulmonary Arterial Hypertension

05/22/2009

FDA Approves Tolvaptan for Patients With Clinically Significant Hypervolemic, Euvolemic Hyponatremia

05/21/2009

Capsaicin Patch Approved for Peripheral Neuropathic Pain in Non-Diabetic Adults

05/20/2009

Sorafenib Approved in Japan for the Treatment of Advanced Liver Cancer

05/18/2009

FDA Approves Risperidone as Maintenance Treatment for Bipolar I Disorder

05/14/2009

Certolizumab Approved in the United States for Moderate to Severe Rheumatoid Arthritis

05/13/2009

FDA Approves Amlodipine, Olmesartan Medoxomil Combination Pill for Hypertension

05/11/2009

EMEA Recommends Extension of Shelf-Life for Oseltamivir Capsules

05/08/2009

FDA Warns of New Serious Adverse Events With Erlotinib

05/07/2009

Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes

05/07/2009

Imatinib Approved in EU to Reduce Relapse Risk After GIST Surgery

05/07/2009

FDA Approves Iloperidone for Schizophrenia

05/06/2009

FDA Grants Accelerated Approval of Bevacizumab for Glioblastoma

05/05/2009

Esomeprazole Approved in EU for Prevention of Peptic Ulcer Re-bleeding Following Endoscopy

05/01/2009

FDA Approves Pancrelipase for Exocrine Pancreatic Insufficiency

04/30/2009

FDA Approves Triple Combination Pill for Hypertension

04/28/2009

Eslicarbazepine Approved in Europe for Partial-Onset Seizures

04/27/2009

Long Acting Risperidone Injection Approved in Japan for Schizophrenia

04/27/2009

Bazedoxifene Approved in EU for Postmenopausal Osteoporosis

04/24/2009

Combination Telmisartan/Hydrochlorothiazide Pill Approved for Treating Hypertension in Japan

04/24/2009

FDA Approves Golimumab for Treating 3 Types of Immune-Related Arthritis

04/23/2009

NICE Appraises Lenalidomide Plus Dexamethasone for Multiple Myeloma

04/23/2009

Etanercept Gets Revised Boxed Warning for Risk of Invasive Fungal Infections

04/23/2009

Hepatitis B Injection Approved for Treating Acute Exposure

04/21/2009

Health Canada Approves Methyl Aminolevulinate Cream for Use With Red Light Technology

04/17/2009

Health Canada Approves Glatiramer Acetate for Clinically Isolated Syndrome Suggestive of MS

04/13/2009

Golimumab Approved for Psoriatic Arthritis, Ankylosing Spondylitis, and RA in Canada

04/08/2009

Manufacturer of Efalizumab Announces Voluntary Withdrawal From US Market

04/02/2009

European Commission Approves Vaccine to Prevent Japanese Encephalitis

04/01/2009

Bevacizumab Recommended for Accelerated Approval for Glioblastoma by FDA

03/31/2009

Health Canada Approves Azithromycin Solution for Bacterial Conjunctivitis

03/31/2009

European Commission Approves 10-Valent Paediatric Pneumococcal Vaccine

03/31/2009

EMEA Removes Restriction of Bevacizumab Use in Patients With Brain Metastases

03/30/2009

FDA Approves Vaccine to Prevent Japanese Encephalitis

03/30/2009

FDA Approves Everolimus for Renal Cell Cancer When Sunitinib or Sorafenib Fail

03/26/2009

Pandemic Influenza Vaccine for Humans Approved in Australia

03/25/2009

NICE Recommends Sunitinib for First-Line Treatment of Renal Cell Carcinoma

03/24/2009

Pioglitazone Hydrochloride Approved in Japan for Use With Insulin in Type 2 Diabetes

03/24/2009

FDA Approves Tigecycline for Community-Acquired Bacterial Pneumonia

03/24/2009

FDA Approves Olanzapine, Fluoxetine HCl for Treatment-Resistant Depression

03/20/2009

FDA Approves Escitalopram Oxalate for Major Depressive Disorder in Adolescents

03/17/2009

Health Canada Approves Hylan GF-20 for Osteoarthritis of the Knee

03/05/2009

FDA, European Commission Approve IV Formulation of Temozolomide

03/04/2009

FDA Approves Glatiramer Acetate for Symptoms Suggestive of MS

02/27/2009

Rituximab Approved in EU for Chronic Lymphocytic Leukaemia

02/26/2009

FDA Approves Intra-Articular Injection for Osteoarthritis of the Knee

02/24/2009

Agomelatine Approved in EU for Major Depressive Episodes

02/23/2009

Prasugrel Approved in EU for Patients With Acute Coronary Syndrome Undergoing PCI

02/19/2009

EMEA Recommends Suspension of Efalizumab, FDA Continues Its Safety Review

02/11/2009

Bevacizumab/Paclitaxel Combination Approved in Canada for First-Line Treatment of HER2-Negative Breast Cancer

02/09/2009

Romiplostim Approved in the EU for Chronic Immune Thrombocytopenic Purpura

02/06/2009

FDA Approves Antithrombin for Prevention of Thromboembolic Events

02/04/2009

Glatiramer Acetate Approved for Patients With Clinical Isolated Syndrome Suggestive of MS

02/04/2009

Once-Daily Darunavir Approved in EU for Treatment-Naïve Adults

02/03/2009

FDA Approves Calcitriol for Mild-to-Moderate Plaque Psoriasis

02/03/2009

Galsulfase Approved in Brazil for the Treatment of Mucopolysaccharidosis VI

01/30/2009

Miglustat Approved in the EU for Niemann-Pick Type C Disease

01/29/2009

Eculizumab Approved in Canada for Paroxysmal Nocturnal Haemoglobinuria (PNH)

01/27/2009

FDA Approves Oxybutynin Chloride Gel for the Treatment of Overactive Bladder

01/23/2009

EMEA Recommends New Contraindication for Toremifene

01/22/2009

Ustekinumab Approved in EU for Moderate to Severe Plaque Psoriasis

01/22/2009

Health Canada Approves Ziprasidone Hydrochloride for Bipolar Disorder

01/21/2009

Tocilizumab Approved in EU for Rheumatoid Arthritis

01/20/2009

Grass Pollens Desensitisation Tablets Approved in Germany for Paediatric Use

01/16/2009

FDA Approves Fibrinogen Concentrate for Congenital Fibrinogen Deficiency

01/15/2009

FDA Approves Milnacipran HCl for Fibromyalgia

01/13/2009

Serious Adverse Effects Reported With Use of Botulinum Toxin Type A

01/12/2009

Etanercept Approved in EU for Treatment of Paediatric Psoriasis

01/12/2009

Three Lots of Dobutamine Hydrochloride Recalled Due to Dose Labelling Error

01/07/2009

Health Canada: Important Changes to the Dose Conversion Guidelines for Fentanyl Transdermal Systems

01/06/2009

FDA Approves Once-Daily Adapalene/Benzoyl Peroxide Gel for Acne Treatment

01/05/2009

FDA Approves Amiodarone HCl for Recurring Ventricular Fibrillation, Ventricular Tachycardia

12/31/2008

FDA Approves First Nucleic Acid Test to Screen for Additional Types of HIV in Donated Blood, Tissue

12/31/2008

Efalizumab Associated With Serious Infections, Progressive Multifocal Leukoencephalopathy

12/29/2008

FDA Approves Degarelix for Advanced Prostate Cancer

12/24/2008

Azacitidine Approved in EU for Myelodysplastic Syndromes, AML

12/22/2008

FDA Approves Gadofosveset Trisodium for Use With MRA to Evaluate Aortoiliac Occlusive Disease

12/22/2008

Pioglitazone Hydrochloride Approved as Concomitant Therapy With Biguanides for Type 2 Diabetes in Japan

12/22/2008

FDA Approves Imatinib Mesylate to Prevent Recurrence of GI Stromal Tumour

12/19/2008

Wide Range of Eye Conditions Reported Following Off-label Use of Bevacizumab

12/19/2008

FDA Approves Oral Formation of Fludarabine for Chronic Lymphocytic Leukaemia

12/17/2008

Erlotinib Linked to Deaths in Patients With Hepatic Impairment, Advanced Solid Tumours

12/17/2008

FDA Approves Plerixafor for Stem Cell Mobilisation in Non-Hodgkin's Lymphoma, Multiple Myeloma Patients

12/16/2008

FDA: Antiepileptics Linked to Increased Risk of Suicidal Thoughts, Behaviour

12/15/2008

FDA Approves Fenofibric Acid in Combination With Statins for Cholesterol Management

12/15/2008

Ustekinumab Approved in Canada for Moderate to Severe Plaque Psoriasis

12/15/2008

Lower-Dose Dasatinib Approved for Patients With Chronic Phase CML

12/15/2008

FDA Approves Fospropofol Disodium for Monitored Anaesthesia Care Sedation

12/12/2008

FDA Approves PEG-IFN Alfa-2b/Ribavirin Combination Therapy for Paediatric HCV

12/11/2008

FDA: Boxed Warning of Oral Sodium Phosphate Products to Include Risk of Acute Phosphate Nephropathy

12/09/2008

Sapropterin Dihydrochloride Approved in EU for Hyperphenylalaninaemia Due to Phenylketonuria, BH4 Deficiency

12/04/2008

European Commission Approves New Indication for Peginterferon Alfa-2a

12/03/2008

European Union Approves Darunavir for Treatment-Experienced Patients

12/03/2008

European Union Approves Brinzolamide/Timolol Suspension for the Treatment of Glaucoma, Ocular Hypertension

12/02/2008

FDA: Increased Risk of Mortality Associated With Tinzaparin Not Limited to Patients Over 90 Years

12/01/2008

FDA Approves Synthetic Conjugated Oestrogens-A Vaginal Cream for Vulvar, Vaginal Atrophy Symptoms

12/01/2008

Cetuximab Approved for First-Line Treatment of Head and Neck Cancer in Europe

11/26/2008

FDA Grants Full Approval of Maraviroc for Treatment-Experienced Patients With HIV

11/24/2008

Phenytoin, Fosphenytoin May Increase Risk of Serious Skin Reactions in Asian Patients With HLA-B*1502 Allele

11/21/2008

FDA Approves Tapentadol for Relief of Moderate to Severe Acute Pain

11/21/2008

Infection-Related Deaths Reported With Alemtuzumab, Warns Health Canada

11/21/2008

FDA Approves Eltrombopag for the Treatment of Chronic Immune Thrombocytopenic Purpura

11/18/2008

FDA Approves Rufinamide as Adjunctive Treatment for Lennox-Gastaut Syndrome

11/18/2008

Methylnaltrexone Bromide Approved in Australia for the Treatment of Opioid-Induced Constipation

11/13/2008

FDA Approves Oestrogen Vaginal Cream for Moderate to Severe Postmenopausal Dyspareunia

11/13/2008

Swissmedic Approves Ceftobiprole Medocaril for Treatment of Complicated Skin Structure Infections

11/06/2008

FDA Approves Ranolazine as First-Line Treatment of Chronic Angina

11/03/2008

FDA Approves Bendamustine Hydrochloride for Patients With Relapsed Indolent Non-Hodgkin's Lymphoma

10/31/2008

FDA Approves Fesoterodine Fumarate to Treat Overactive Bladder

10/30/2008

Health Canada Warns of Venlafaxine Overdosage, Increased Risk of Fatal Outcome

10/29/2008

FDA Approves Rapid-Acting Insulin Glulisine for Children With Diabetes

10/29/2008

FDA Approves Lacosamide for Uncontrolled Partial-Onset Seizures

10/29/2008

Single-Pill Combination Receives Swiss Approval for Treatment of Hypertension

10/29/2008

Health Canada Approves Cetuximab for Advanced Colorectal Cancer, Head and Neck Cancer

10/23/2008

European Medicines Agency Recommends Suspension of Rimonabant

10/22/2008

Darunavir Receives Expanded Indication From FDA for Treatment-Naïve Adults

10/21/2008

Alitretinoin Approved in France for Adults With Chronic Hand Eczema

10/17/2008

Ethex Recalls 3 Lots of Dextroamphetamine Sulfate Due to Oversized Tablets

10/16/2008

Pirfenidone Approved in Japan for Treatment of Idiopathic Pulmonary Fibrosis

10/16/2008

FDA Approves Labeling Changes, Boxed Warning for Efalizumab

10/16/2008

FDA Approves Denileukin Diftitox for Patients With Recurrent Cutaneous T-Cell Lymphoma

10/16/2008

Nanoparticle Albumin-Bound Paclitaxel Approved in Australia for Metastatic Breast Cancer

10/14/2008

Warning Label for Acetaminophen With Codeine to Include Nursing Mothers With Ultra-Rapid Metabolisers

10/14/2008

Health Canada Approves Liquid Immune Globulin IV for Chronic Inflammatory Demyelinating Polyneuropathy

10/10/2008

FDA Approves Drug to Prevent Joint Damage in Children with Haemophilia A

10/10/2008

FDA Approves C1 Inhibitor Protein for the Prevention of Hereditary Angioedema Attacks

10/10/2008

FDA Approves Quetiapine Fumarate for the Treatment of Bipolar Depression, Mania

10/09/2008

Histamine Dihydrochloride Approved in Europe for Prevention of Relapse in Patients With AML

10/09/2008

FDA Approves Silodosin for the Treatment of Benign Prostatic Hyperplasia

10/06/2008

Health Canada Approves Lenalidomide for Treatment of Multiple Myeloma

10/02/2008

FDA Approves Atazanavir Boosted With Ritonavir for Treatment-Naïve HIV Patients

10/01/2008

Rivaroxaban Approved in EU for the Prevention of Venous Thromboembolic Events

09/30/2008

Once-yearly Zoledronic Acid Approved in EU to Treat Osteoporosis in Men

09/23/2008

FDA Approves Triamcinolone Acetonide for Allergic Rhinitis in Children Aged 2 to 5 years

09/22/2008

Alitretinoin Approved in Denmark for Adults With Chronic Hand Eczema

09/16/2008

Rivaroxaban Approved in Canada for the Prevention of Venous Thromboembolic Events

09/15/2008

FDA Approves Expanded Uses for HPV Vaccine to Include Prevention of Certain Vulvar, Vaginal Cancers

09/15/2008

FDA Approves Granisetron Patch for Chemotherapy-Induced Nausea, Vomiting

09/15/2008

FDA Approves Once-Daily Levetiracetam as Adjunctive Therapy for Partial Onset Seizures

09/12/2008

FDA Approves Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

09/11/2008

FDA: Fatal Case of Progressive Multifocal Leukoencephalopathy in Patient Receiving Rituximab

09/10/2008

Bortezomib Combination Therapy Approved in Europe for Previously Untreated Multiple Myeloma

09/08/2008

Bortezomib Approved in Canada as First-Line Treatment of Multiple Myeloma

09/04/2008

FDA: TNF Blockers Increase Risk of Invasive Fungal Infections, Delayed Treatment Can Result in Death

09/03/2008

Lacosamide Approved in Europe for Partial-Onset Epilepsy

09/02/2008

Health Canada Approves Ceftobiprole Medocaril for Treatment of Complicated Skin Structure Infections

08/29/2008

Etravirine Approved in the European Union for HIV Combination Therapy

08/27/2008

NICE Final Guidance on Ranibizumab, Pegaptanib for Age-Related Macular Degeneration

08/26/2008

Vaccine for the Prevention of Shingles Approved in Canada

08/26/2008

Alutard SQ Approved for Asthma Prevention in Germany

08/25/2008

FDA to Amend Natalizumab Label Based on New Cases of PML in Europe

08/25/2008

Tramadol Receives Expanded Indication in Canada for Moderately Severe Pain

08/22/2008

FDA Approves Romiplostim to Treat Chronic Immune Thrombocytopenic Purpura

08/21/2008

FDA Investigating Possible Link Between Ezetimibe/Simvastatin and Increased Cancer Risk

08/21/2008

Teriparatide Approved in Canada for Steroid-Induced Osteoporosis

08/20/2008

Calcipotriene, Betamethasone Dipropionate Gel Approved in Europe for Scalp Psoriasis

08/18/2008

FDA Receives More Reports of Acute Pancreatitis in Patients Taking Exenatide

08/15/2008

FDA Approves Tetrabenazine for Treatment of Chorea in Huntington's Disease

08/12/2008

FDA Issues Warning for Naltrexone Injection Site Reactions

08/12/2008

Tenofovir Approved for Treatment of Chronic Hepatitis B in Adults

08/12/2008

Temsirolimus Associated With Hypersensitivity/Infusion Reactions, Warns Health Canada

08/08/2008

FDA: Watch for Rhabdomyolysis When Simvastatin, Amiodarone Are Coadministered

08/06/2008

Single Lot of Epoetin Alfa Recalled Due to Damaged Vials

08/06/2008

EU Extends Indication of Bosentan to Pulmonary Arterial Hypertension WHO FC II

08/06/2008

FDA Approves Expanded Use of Caspofungin Acetate for Paediatric Patients

08/05/2008

FDA Approves 6 Flu Vaccines for 2008-2009 Influenza Season

08/05/2008

FDA Approves Injectable Clevidipine Butyrate for Treatment of Hypertension

08/04/2008

Naltrexone Approved in Russia for Treatment of Alcohol Dependence

08/04/2008

FDA Approves Single Combination Pills for First-Line Treatment of Hypertension

07/31/2008

FDA Clarifies Approved Conditions for Use of ESAs

07/30/2008

FDA Approves Valproate for Bipolar Disorder, Seizures, and Migraine Headaches

07/29/2008

FDA: Watch Cardiac Function in MS Patients During and After Mitoxantrone Therapy

07/24/2008

EMEA Recommends Strengthened Warnings, Restricted Use of Oral Moxifloxacin

07/24/2008

Contaminated Nelfinavir Does Not Increase Cancer Risk, EMEA Concludes

07/24/2008

EMEA Restricts Use of Oral Norfloxacin Drugs in UTIs

07/24/2008

FDA Recommends Genetic Screening Prior to Treatment With Abacavir

07/23/2008

Cetuximab as First-Line Treatment in Metastatic Colorectal Cancer Approved in Europe

07/22/2008

Sitagliptin/Metformin HCl Approved in Europe for Type 2 Diabetes

07/18/2008

Sandoz Timolol Ophthalmic Solution Recalled Due to Potential Health Risk

07/18/2008

Intranasal Desmopressin Loses Indication for Primary Nocturnal Enuresis in Canada

07/16/2008

Cetuximab Approved in Japan for Treatment of Metastatic Colorectal Cancer

07/16/2008

Argatroban Hydrate Receives Expanded Approval for Thrombosis in Japan

07/15/2008

European Commission Approves Icatibant for the Treatment of Hereditary Angio-Oedema

07/14/2008

Bevacizumab Plus Sunitinib Linked to Rare Anaemia in Patients With Solid Tumours, Warns FDA

07/14/2008

European Commission Approves Nicotinic Acid/Laropiprant for Treatment of Hypercholesterolaemia

07/14/2008

Albumin-Bound Paclitaxel Approved for Metastatic Breast Cancer in China

07/11/2008

Bevacizumab Plus Sunitinib Linked to Rare Anaemia in Metastatic Renal Cancer, Warns Health Canada

07/10/2008

European Commission Approves Ranolazine for Treatment of Patients With Chronic Angina

07/09/2008

Ratio-Morphine Tablets Recalled in Canada Due to Risk of Accidental Overdose

07/08/2008

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

07/08/2008

European Commission Approves Once-Weekly Etanercept for Psoriasis

07/03/2008

European Commission Approves Methylnaltrexone Bromide for Opioid-Induced Constipation in Advanced Illness

07/01/2008

FDA Approves Rabeprazole for Short-Term Treatment of GERD in Adolescents

06/30/2008

Ceftobiprole Approved in Canada for Treatment of Complicated Skin Infections

06/27/2008

EMEA Recommends New Warning Label for Epoetin-Containing Medication

06/27/2008

EMEA Recommends Updated Label Warnings for Etoricoxib-Containing Drugs

06/27/2008

FDA Approves Methylphenidate HCl Extended-Release Tablets for Treatment of ADHD in Adults

06/26/2008

Sublingual Fentanyl Approved in Europe for Breakthrough Cancer Pain

06/26/2008

European Commission Approves Shortened Treatment With Peginterferon Alfa-2a Plus Ribavirin for Specific Hepatitis C Patients

06/25/2008

Potential Risk of Cardiac Events in Patients Treated With Abacavir-Containing Products

06/25/2008

Oralair Grasses Approved for Adults With Allergic Rhinoconjunctivitis in Germany

06/25/2008

FDA Approves New Combination Vaccine for Children

06/24/2008

FDA Approves New Tipranavir Oral Solution for Treatment-Experienced Paediatric, Adolescent HIV Patients

06/24/2008

FDA Approves Topical Steroid for Treatment of Postoperative Ocular Inflammation, Pain

06/24/2008

FDA Gives Nod to New Diabetes Combination Tablet: Repaglinide + Metformin

06/23/2008

FDA Approves Pentacel, a Paediatric Combination Vaccine

06/23/2008

FDA Approves Bortezomib for Patients With Previously Untreated Multiple Myeloma

06/23/2008

FDA Approves Dutasteride in Combination With Tamsulosin for the Treatment of Symptomatic Enlarged Prostate

06/18/2008

FDA Approves Diaphragm-Pacing Device

06/18/2008

FDA Requests Boxed Warnings on Conventional Antipsychotic Drugs

06/17/2008

TGA Approves Panvax, Avian Flu Vaccine

06/17/2008

FDA Approves Triamcinolone Acetone Formulation for Ocular Use

06/16/2008

Oral Anticoagulant Dabigatran Etexilate Approved in Canada

06/16/2008

FDA Approves Duloxetine HCl for the Management of Fibromyalgia

06/13/2008

Lapatinib Approved in Europe for Breast Cancer

06/10/2008

Single Lot of Morphine Sulfate 60-mg Extended Release Tablets Recalled

06/07/2008

Health Canada Approves New Treatment for Bipolar Mania

06/07/2008

US FDA Announces New Labelling Changes for Becaplermin

06/05/2008

US FDA Approves Zoledronic Acid for Prevention of Fractures Following a Hip Fracture

05/30/2008

Alteplase Approved in European Union for Catheter Dysfunction Caused by Thrombotic Occlusion

05/27/2008

Idursulfase Approved in Brazil for Treatment of Hunter Syndrome

05/27/2008

FDA Approves Thrombin, Topical (Recombinant), 20,000-IU Vial Size for Haemostasis

05/27/2008

Interferon Beta-1b (Extavia) Approved in European Union for Treatment of Multiple Sclerosis

05/21/2008

FDA Approves Alvimopan to Help Restore Bowel Function Following Surgery

05/20/2008

Pre-Pandemic Vaccine Approved in EU to Protect Against H5N1 Influenza

05/20/2008

Reformulated Liquid Sargramostim Now Available in the US

05/19/2008

Medicis Voluntarily Recalls Solodyn (Minocycline HCl) Extended Release Due to Product Mix-Up

05/16/2008

CDC Recommends Vaccine for Shingles

05/15/2008

Bayer Removes Remaining Stocks of Aprotinin; Access Limited to Investigational Use

05/14/2008

FDA Approves Quetiapine for Maintenance Treatment in Bipolar Disorder

05/13/2008

Topotecan Approved in Europe for Treatment of Relapsed Small-Cell Lung Cancer

05/12/2008

FDA Approves New Formulation of Coagulation Therapy That Can Be Stored at Room Temperature

05/09/2008

FDA Approves Generic Ropinirole Hydrochloride for Treatment of Restless Legs Syndrome

05/09/2008

FDA Approves Aripiprazole as Adjunctive to Lithium or Valproate in Adults With Bipolar 1 Disorder

05/09/2008

Aripiprazole Receives Expanded Paediatric Indications for Bipolar I Disorder and Schizophrenia

05/09/2008

FDA Approves Atomoxetine for Maintenance of ADHD in Children and Adolescents

05/07/2008

Micafungin Approved in Europe for Treatment and Prevention of Fungal Infections

05/07/2008

Low-Dose, Drospirenone-Containing Oral Contraceptive Approved in Europe

05/06/2008

Febuxostat Approved in Europe for the Treatment of Chronic Hyperuricaemia in Patients With Gout

05/01/2008

FDA Approves Fluticasone/Salmeterol Inhalation Powder for Reduction of COPD Exacerbations

04/30/2008

FDA Approves Lubiprostone as First Drug Treatment for IBS With Constipation

04/29/2008

US Recalls Some Digoxin Tablets, May Contain Twice the Approved Level of Active Ingredient

04/28/2008

Tipranavir Approved in Europe for Suppression Treatment of HIV

04/28/2008

90Y-Ibritumomab Tiuxetan Approved in Europe for Treatment of Follicular Lymphoma

04/25/2008

Tenofovir Disoproxil Fumarate Approved in Europe for Treatment of Chronic Hepatitis B

04/25/2008

Methylnaltrexone Bromide Receives FDA Approval for Opioid-Induced Constipation

04/24/2008

FDA Approves Once-Daily Lisdexamfetamine to Treat ADHD in Adults

04/22/2008

Dutasteride Plus Tamsulosin Approved for Benign Prostatic Hyperplasia in Sweden

04/22/2008

Sunitinib Approved in Japan for GIST and Renal Cell Carcinoma

04/22/2008

FDA Approves Certolizumab to Treat Crohn's Disease

04/21/2008

Europe Approves New Fixed-Dose Combination Drug for Essential Hypertension

04/21/2008

Thalidomide Agent Approved in the European Union for the Treatment of Newly Diagnosed Multiple Myeloma

04/17/2008

FDA Finds Generic Bupropion XL Safe and Effective

04/17/2008

Tocilizumab Approved in Japan for the Treatment of Rheumatoid Arthritis

04/17/2008

FDA Approves Combination Sumatriptan/Naproxen Sodium for Acute Treatment of Migraine

04/16/2008

FDA Approves Olopatadine Nasal Spray for Treatment of Nasal Allergy Symptoms

04/14/2008

Fixed-Dose Combination 80 mg Telmisartan/25 mg Hydrochlorothiazide Approved in Europe for the Treatment of Essential Hypertension

04/14/2008

Fentanyl Approved in Europe for the Treatment of Breakthrough Cancer Pain

04/11/2008

Pemetrexed Approved in Europe for Histologically-Based First-Line Treatment of Advanced Non-Small-Cell Lung Cancer

04/10/2008

FDA Investigates Reports of PML in Patients Taking Mycophenolate Mofetil and Mycophenolic Acid

04/08/2008

FDA Approves Abatacept for the Treatment of Polyarticular Juvenile Idiopathic Arthritis

04/08/2008

Cancer Vaccine Approved in Russia for Patients With Intermediate-Risk Renal Cell Carcinoma

04/08/2008

European Commission Approves Aripiprazole for Bipolar I Disorder

04/07/2008

Lower-Strength Lopinavir/Ritonavir Tablet Approved in Europe for Paediatric Patients With HIV

04/07/2008

Australian Agency Approves Thalidomide for the Treatment of Newly Diagnosed Multiple Myeloma

04/04/2008

European Commission Approves Teriparatide for the Treatment of Glucocorticoid-Induced Osteoporosis

04/04/2008

FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus

04/03/2008

Covidien Initiates Voluntary Recall of Pre-Filled Syringes Containing Heparin

03/27/2008

Dabigatran Approved in Europe for Thromboprophylaxis Following Hip or Knee Replacement Surgery

03/27/2008

Becaplermin May Increase Risk of Death From Cancer in Patients With Diabetes

03/27/2008

US FDA Issues Update of Ongoing HIV Drug Safety Review

03/27/2008

Possible Link Between Montelukast and Suicidality, US FDA Investigates

03/26/2008

Valsartan Approved in Canada for the Treatment of Patients With Chronic Heart Failure

03/20/2008

FDA Approves Bendamustine Hydrochloride for Use in Chronic Lymphocytic Leukaemia

03/20/2008

European Agency Warns of Potential Liver Injury With Natalizumab Treatment

03/20/2008

UCB Advises US-Physicians to Down-Titrate Patients on Neupro in View of Out-Of-Stock Situation in the US

03/20/2008

FDA Approves New Medical Adhesive to Treat Burn Patients

03/18/2008

FDA Approves First Insulin Analog for Use in Insulin Pumps by Children, Adolescents

03/17/2008

Etanercept PI Gets Boxed Warning for Risk of Infections, Tuberculosis

03/11/2008

Misuse of Hydrocodone-Containing Cough Suppressant Linked to Life-Threatening Adverse Events

03/04/2008

Oral Verapamil HCl Approved in Japan for Tachyarrhythmia

03/03/2008

FDA Approves Palonosetron for Prevention of Postoperative Nausea and Vomiting

03/03/2008

FDA Approves Desvenlafaxine for Treatment of Adults With Major Depressive Disorder

03/03/2008

Actavis Recalls Remaining Fentanyl Patches in the US as Precaution

03/03/2008

FDA Approves Three New Dosage Strengths of Oxymorphone HCl Extended Release

02/29/2008

FDA Approves Aripiprazole for Paediatric Patients With Bipolar Disorder

02/28/2008

Baxter to Recall Remaining Heparin Vial Products

02/28/2008

FDA Approves Rilonacept for the Treatment of Rare Inflammatory Syndromes

02/28/2008

FDA Approves Esomeprazole for Use in Children Ages 1-11 Years

02/25/2008

Single-Tablet Galvus/Metformin Approved in EU for Patients With Type 2 Diabetes

02/22/2008

FDA Approves Bevacizumab for Metastatic Breast Cancer

02/22/2008

FDA Approves Adalimumab for the Treatment of Juvenile Idiopathic Arthritis

02/21/2008

FDA Licenses New Hemophilia Treatment

02/19/2008

FDA Approves Xyzal (Levocetirizine Dihydrochloride) Oral Solution for Allergic Rhinitis and Chronic Idiopathic Urticaria

02/18/2008

Potential Defect Triggers Another Recall of Fentanyl Patches in the US

02/12/2008

Fentanyl 25 mcg Patches Recalled

02/11/2008

Baxter's Multiple-Dose Vial Heparin Linked to Severe Allergic Reactions

02/08/2008

FDA: Botulinum Toxins Linked to Respiratory Failure and Death

02/04/2008

FDA Approves Asmanex Twisthaler for Asthma Maintenance in Pediatric Patients

02/01/2008

Galvus Approved in European Union for Treatment of Type 2 Diabetes

01/31/2008

FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation

01/29/2008

Champix Approved in Japan as Smoking Cessation Aid

01/29/2008

Angiox Receives European Authorization for Expanded Use in Patients with Acute Coronary Syndromes

01/29/2008

FDA Approves Emend Injections for Prevention of Nausea and Vomiting Caused by Chemotherapy

01/28/2008

Clexane/Lovenox Approved in Japan for Thrombosis Prevention in Orthopaedic Surgery Patients

01/28/2008

Avastin Receives Label Extension in Europe for Treatment of Patients With Metastatic Colorectal Cancer

01/28/2008

Sorafenib (Nexavar) Approved in Japan for Treatment of Advanced Renal Cell Carcinoma

01/25/2008

FDA to Conduct a Review of Vytorin's ENHANCE Trial Once the Final Study Results Are Available

01/24/2008

EMEA Statement on the Safety of Gardasil

01/24/2008

EMEA Recommends New Warnings and Contraindications for Rosiglitazone

01/23/2008

Bayer Withdraws Liquid Formulation of Leukine (sargramostim) in US Due to Adverse Reactions

01/21/2008

Tekturna HCT Receives US Approval For Treatment of High Blood Pressure

01/21/2008

Humira (adalimumab) Receives FDA Approval for Moderate to Severe Chronic Plaque Psoriasis

01/21/2008

FDA Issues Recall of Heparin

01/21/2008

FDA Approves New HIV Drug After Priority Review

01/18/2008

FDA Approves Update to Label on Birth Control Patch

01/18/2008

FDA Releases Recommendations Regarding Use of Over-the-Counter Cough and Cold Products

01/18/2008

Chantix (varenicline) Label Updated to Include Warning for Neuropsychiatric Symptoms

01/18/2008

FDA Approves First Clotting Solution Made Using Recombinant DNA Technology

01/16/2008

FDA Issues Public Health Advisory for Edetate Disodium

01/16/2008

Allergic Rhinitis Treatment Avamys (fluticasone furoate) Approved in Europe

01/14/2008

FDA Approves TYSABRI® (natalizumab) for the Treatment of Moderate-to-Severe Crohn's Disease

01/09/2008

FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

01/08/2008

FDA Approves Cialis (tadalafil) for Once Daily Use for the Treatment of Erectile Dysfunction

01/07/2008

FDA Provides Updated Information on Bisphosphonates

12/28/2007

Ultiva (Remifentanil hydrochloride) Recalled in Canada Due to Potential for Overdose

12/28/2007

FDA Approves Product to Treat Serious Blood Volume Loss following Surgery

12/21/2007

Health Canada Endorses Safety Information on Modafinil (Alertec)

12/21/2007

Important Information for the Safe Use of Fentanyl Transdermal System (Patch)

12/20/2007

CDC, AAFP, Others Release Interim Hib Vaccine Recommendations

12/20/2007

Abbott's HUMIRA® Approved in the European Union for Treatment of Moderate-to-Severe Plaque Psoriasis

12/19/2007

Avastin Approved in Europe for First-Line Treatment of Patients with Advanced Kidney Cancer

12/17/2007

European Commission Approves Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)

12/12/2007

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

12/04/2007

FDA Alert: Desmopressin Acetate Linked to Seizures, Death in Children With PNE

12/03/2007

FDA Approves Diovan® for Treatment of High Blood Pressure in Children

11/30/2007

FDA Approves Cymbalta® for Maintenance Treatment of Major Depressive Disorder

11/29/2007

AstraZeneca Receives European Approval for Nexium in Paediatric GERD

11/29/2007

Merck KGaA's Cyanokit Approved in the European Union

11/28/2007

Tasigna® Gains European Approval for Patients With a Life-Threatening Form of Leukemia Who Are Resistant Or Intolerant to Existing Therapies

11/28/2007

Health Canada Approves ERAXIS(TM) (anidulafungin), a New Antifungal Agent with Potent Effect Against Life-Threatening Fungal Infections

11/27/2007

FDA Issues Safety Warning Over Myfortic (mycophenolic acid) Delayed-Release Tablets

11/26/2007

Health Canada Issues an Update on Availability of Trasylol (aprotinin)

11/26/2007

Wyeth's Torisel Receives European Commission Approval for the Treatment of Advanced Kidney Cancer

11/20/2007

FDA Reviewing Post-Marketing Cases Describing Suicidal Ideation and Occasional Suicidal Behavior With Chantix (Varenicline)

11/20/2007

Abilify(R) (Aripiprazole) Approved by U.S. FDA for Add-On Treatment of Major Depressive Disorder

11/20/2007

FDA Approves Avalide® (irbesartan-hydrochlorothiazide) as First Combination Therapy for Initial Use in Patients Likely to Need Multiple Drugs to Achieve Blood Pressure Goals

11/19/2007

FDA Notice of Potentially Harmful "Cosmetic" Eye Product

11/19/2007

FDA Approves Nexavar for Treatment of Liver Cancer

11/19/2007

Sale of Prexige (Lumiracoxib) Suspended in UK and Germany

11/19/2007

Prexige (Lumiracoxib) License Suspended in UK

11/16/2007

EMEA Recommends Changes in Product Information for Protelos/Osseor Due to Risk of Severe Hypersensitivity Reactions

11/16/2007

FDA Approves Protonix(R) pantoprazole sodium) for Delayed-Release Oral Suspension for Erosive Gastroesophageal Reflux Disease

11/16/2007

Seroquel XR(TM) (quetiapine fumarate) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

11/15/2007

New Crestor(R) (rosuvastatin calcium) Indication Approved in U.S. to Slow Progression of Atherosclerosis in Patients With High Cholesterol

11/15/2007

Pegintron(TM) (peginterferon alfa-2b) and Rebetol(R) (ribavirin) Approved in European Union for Retreating Hepatitis C Patients Who Failed Previous Pegylated or Non-Pegylated Interferon Therapy

11/15/2007

U.S. FDA Approves Lower-Strength Kaletra(R) (lopinavir/ritonavir) Tablet for Pediatric HIV Patients

11/15/2007

FDA Approves Mircera (methoxy polyethylene glycol-epoetin beta) for Treatment of Renal Anemia in US With Monthly Maintenance Dosing

11/15/2007

Cefepime (Maxipime) - Early Communication About An Ongoing Safety Review

11/14/2007

Natrecor Authorized in Canada for Treatment of Acute Decompensated Heart Failure

11/14/2007

FDA Adds Boxed Warning for Heart Attacks to Anti-Diabetes Drug Avandia

11/13/2007

Nexavar Becomes First Approved Systemic Treatment of Hepatocellular Carcinoma in Europe

11/09/2007

FDA Approves New Sprycel(R) (Dasatinib) Product Labeling for Patients With Chronic-Phase CML

11/08/2007

FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents

11/06/2007

Aclasta(R) (Zoledronic Acid) receives Health Canada approval as first and only once-yearly treatment for women with postmenopausal osteoporosis

11/06/2007

U.S. FDA Approves Abilify® (Aripiprazole) for Adolescent Patients With Schizophrenia

11/05/2007

FDA Requests Marketing Suspension of Trasylol

10/31/2007

FDA Approves CombiganTM (Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution) for Reduction of Intraocular Pressure

10/30/2007

Tasigna® (Nilotinib) Receives U.S. Approval for Chronic Myeloid Leukemia in Patients With Resistance or Intolerance to Existing Therapies

10/30/2007

Nexavar® (Sorafenib) Approved for Hepatocellular Carcinoma in Europe

10/29/2007

FDA Medwatch: Use of CellCept (Mycophenolate Mofetil) Associated With Increased Pregnancy Loss and Congenital Malformations

10/25/2007

Early Communication about an Ongoing Safety Review - Aprotinin Injection (marketed as Trasylol)

10/24/2007

Provigil (modafinil) Tablets - Warnings Added to Prescribing Information Regarding Serious Rash and Hypersensitivity Reactions, and Psychiatric Symptoms

10/24/2007

FDA Announces Revisions to Labels for Cialis, Levitra and Viagra

10/22/2007

FDA Approves Change in Storage Conditions for Humate-P

10/19/2007

Important Safety Information Released on Definity(R) (Perflutren Injectable Suspension) and Serious Cardiopulmonary Reactions

10/19/2007

FDA Expands Age Range for Use of Bacterial Meningitis Vaccine

10/18/2007

FDA Approves Ixabepilone for the Treatment of Advanced Breast Cancer

10/18/2007

FDA Approves New HIV Drug, Raltegravir Tablets, Used in Combination With Other Antiretroviral Agents

10/18/2007

FDA Approves New Drug to Treat Complicated Urinary Tract and Intra-Abdominal Infections

10/18/2007

European Medicines Agency Recommends Withdrawal of Marketing Authorisations for Cough Medicines Containing Clobutinol

10/17/2007

FDA Approves New Treatment for Diabetes

10/16/2007

Byetta (Exenatide) and Postmarketing Reports of Acute Pancreatitis

10/15/2007

Contraindicated Use of Sibutramine and Cardiovascular Adverse Reactions

10/12/2007

Reports of Deaths and Serious Cardiopulmonary Reactions Following Administration of Ultrasound Micro-Bubble Contrast Agents Used in Echocardiography

10/11/2007

Iressa® (gefitinib) 250 mg Tablets Fail to Demonstrate Non-inferiority in Overall Survival Versus Docetaxel

10/11/2007

Pediatric Cough and Cold Remedies Recalled by Manufacturers

10/08/2007

Intravascular Ultrasound Crucial in Assessing Atherosclerosis After Statin Therapy: Presented at DALM

10/08/2007

With Ezetimibe, the novel MTP Inhibitor, AEGR-733, Lowers LDL-C in Statin-Intolerant Patients: Presented at DALM

10/08/2007

Cholesterol-Lowering Ezetimibe/Simvastatin Is a Novel Way for Type 2 Diabetes Patients to Reduce CVD Risk: Presented at DALM

10/08/2007

Anti-Depressant Drugs Can Double Risk of Gastrointestinal Bleeding

10/08/2007

Tablet is better all round for cancer patients

10/08/2007

Atorvastatin's Effect in Alzheimer's Dementia -- Preliminary Data from LEADe: Presented at DALM

10/04/2007

Withdrawal of Market Authorization for Prexige (Lumiracoxib)

10/02/2007

Early Communication Issued Regarding Atrial Fibrillation With Oral and Intravenous Bisphosphonates

10/01/2007

Letter Issued Regarding Boxed Warning and Revisions to Warning Section of Prescribing Information for Gadolinium-Based Contrast Agent

09/28/2007

Additional Influenza Vaccine Approved for Upcoming Influenza Season

09/28/2007

FDA Takes Action to Stop Marketing of Unapproved Hydrocodone Products

09/28/2007

Health Canada Recalls Sodium Phosphates Injection, USP Due to Out of Specification Result for Aluminum Content

09/26/2007

FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug

09/21/2007

Axcil and Desirin Dietary Supplements Recalled Because They Were Found to Contain Potentially Harmful Ingredients

09/21/2007

European Medicines Agency Recommends Restricted Use of Nimesulide-containing Medicinal Products

09/20/2007

FDA Proposing Phase Out of CFCs in Metered-Dose Inhalers for Epinephrine

09/20/2007

European Medicines Agency recommends lifting of suspension for Viracept (Nelfinavir, as Nelfinavir Mesilate)

09/18/2007

Haloperidol Marketed as Haldol, Haldol Decanoate, and Haldol Lactate Get New Warnings and Revised Prescription Information

09/13/2007

Letter to Health Care Providers Sent Out With Safety Information Regarding Fentora (Fentanyl Buccal Tablet)

09/11/2007

Letter to Physicians Sent to Clarify Potential Risk Associated With Concomitant Use of Rocephin (Ceftriaxone Sodium) With Calcium Containing Products

09/10/2007

Viracept (Nelfinavir Mesylate) Guidance on Use in Pregnant Women and Pediatric Patients Due to Presence of Potential Human Carcinogen

09/10/2007

Access Granted for New Treatment Option for Scots With Stomach Cancer

09/07/2007

Zencore Tabs Dietary Supplement Recalled - Found to Contain Potentially Harmful Ingredients

09/05/2007

Ketek (telithromycin) No Longer Approved in Canada for Treatment of Bronchitis, Sinusitis or Tonsillitis/Pharyngitis

09/04/2007

FDA Approves Second-Generation Smallpox Vaccine

08/31/2007

FDA Approves New Drug to Treat Rare Disease, Acromegaly

08/29/2007

FDA Approves Human Thrombin for Topical Use in Surgery

08/23/2007

Safety Information Regarding Thelin (Sitaxsentan Sodium) and the Occurrence of Liver Toxicity, Risks to the Foetus, and Important Drug-Drug Interactions

08/22/2007

FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents

08/17/2007

FDA Warning - Codeine Use by Nursing Mothers May Increase Chance of Serious Side Effects in Infants

08/16/2007

Baraclude (Entecavir) Not Recommended for HIV/HBV Co-Infected Patients Who Are Not Also Receiving HAART Due to Potential for Development of HIV Resistance

08/16/2007

FDA Approves Updated Warfarin (Coumadin) Prescribing Information

08/16/2007

New Safety Information Regarding Prexige (Lumiracoxib)

08/16/2007

Eli Lilly to Cease Sale of Permax Due to Risk of Cardiac Valvulopathy

08/14/2007

Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk

08/14/2007

Kaletra (Lopinavir/Ritonavir) Oral Solution - Healthcare Provider Letter Regarding Proper Dosing for Kaletra Oral Solution

08/14/2007

FDA Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs Under President's AIDS Relief Plan

08/10/2007

New Cause of Tamoxifen Resistance in Breast Cancer Cells Discovered at Lombardi

08/09/2007

Prilosec (omeprazole), Nexium (esomeprazole) - Early Communication About Ongoing Safety Review

08/07/2007

FDA Approves Maraviroc for Adults With HIV

07/27/2007

FDA Permits Restricted Use of Zelnorm for Qualifying Patients

07/23/2007

Health Canada Warns Consumers Not to Use Zencore Tabs Due to Potential Health Risks

07/23/2007

European Medicines Agency recommends withdrawal of medicinal products containing veralipride

07/19/2007

European Medicines Agency Recommends Acomplia Must Not Be Used in Patients on Antidepressants or With Major Depression

07/06/2007

Rocephin (Ceftriaxone Sodium) - Contraindications, Warnings, Precautions, Adverse Reactions, Dosage and Administration Sections of Labeling Revised

07/05/2007

Merck Recalls 3 Lots of Invanz (ertapenem sodium) Injection Because the Product May Contain Broken Glass Pieces in the Reconstituted Solution for Injection

06/27/2007

Voluntary Recall of One Lot of Fluotic® (sodium fluoride) 20 mg tablets and Notice of Product Discontinuation

06/27/2007

Sensipar® No Longer Indicated for Chronic Kidney Disease Patients (Stages 3 and 4) Not Receiving Dialysis

06/21/2007

FDA Approves First Drug for Treating Fibromyalgia

06/18/2007

FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

06/12/2007

Association of Avastin With Tracheoesophageal Fistula

06/06/2007

Roche Recalls Viracept Due to Chemical Impurity

05/31/2007

FDA Approves New Drug for Advanced Kidney Cancer

05/28/2007

Novel Chloride Channel Activator Relieves Symptoms of Irritable Bowel Syndrome: Presented at DDW

05/23/2007

FDA Requests Boxed Warning for Contrast Agents Used to Improve MRI Images

05/22/2007

FDA Approves Contraceptive for Continuous Use

05/22/2007

FDA notifies healthcare professionals of changes to Exjade labeling

05/21/2007

FDA Issues Safety Alert on Avandia

05/16/2007

FDA Approves Expanded Use for Surgical Sealant

05/15/2007

Irish Board Suspends Marketing of Drugs Containing Nimesulide

05/11/2007

FDA Approves Neupro Patch for Treatment of Early Parkinson's Disease

05/02/2007

FDA Proposes New Warnings About Young Adults Taking Antidepressants

04/30/2007

FDA Approves Product to Treat Common Bleeding Disorder

04/18/2007

FDA Approves First U.S. Vaccine for Humans Against Bird Flu

04/13/2007

FDA Approves Antibiotic Ointment for Children and Adults

04/02/2007

FDA Approves First Biologic to Treat Rare Clotting Disorder

03/16/2007

FDA Approves First-of-its-Kind Drug to Treat Rare Blood Disorder

03/14/2007

FDA Approves Tykerb for Advanced Breast Cancer

03/07/2007

FDA Approves New Drug Treatment for High Blood Pressure

02/28/2007

FDA Approves New Treatment For Crohn's Disease

02/22/2007

Phase III Study Results: Avastin for Advanced Lung Cancer

02/21/2007

FDA Calls for ADHD Patient Medication Guides

02/13/2007

Information on RotaTeq Vaccine and Intussusception

02/12/2007

FDA Announces Label and Indication Changes for the Antibiotic Ketek

02/09/2007

Medical Therapy for Restless Legs Syndrome May Trigger Compulsive Gambling

02/08/2007

FDA Approves Orlistat for Over-the-Counter Use

02/02/2007

BDSI Announces FDA Acceptance of Bioral(R) Amphotericin Investigational New Drug Application

02/02/2007

GlaxoSmithKline Receives Approvable Letter for New Indications for Arixtra(R) (Fondaparinux Sodium) Injection

02/01/2007

Grifols Announces FDA Approval of Alphanate(R) to Treat von Willebrand Disease

01/30/2007

FDA Approves NovoLog(R) (Insulin Aspart [rDNA Origin] Injection) Category Change for Use in Pregnant Women with Type 1 Diabetes

01/30/2007

Innovative Long-Acting Contraceptive Product Mirena(R) Approved in Japan

01/29/2007

Pharmion Corporation Announces FDA Approval of Vidaza NDA Supplement for IV Administration

01/29/2007

Tarceva: European Approval for Pancreatic Cancer Treatment Important New Therapy Option for Patients Suffering From One of the Deadliest Cancers

01/29/2007

FDA Approves New Indication for YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) to Treat Acne

01/26/2007

Study Suggests Thrombolysis Therapy With Alteplase Could Be Used Routinely for Stroke Treatment

01/26/2007

Copegus Approved in Japan as Combination Therapy With Pegasys for Patients With Chronic Hepatitis C

01/25/2007

FDA Advisory Committee Recommends Licensure of New Pediatric Combination Vaccine

01/25/2007

Bayer Discontinues Trasylol® (Aprotinin Injection) Clinical Trial Program in Non-CABG Indications

01/25/2007

Committee for Medicinal Products for Human Use Post-Authorisation Summary of Positive Opinion* for Xyrem (Sodium Oxybate)

01/25/2007

Januvia™ (Sitagliptin Phosphate), First in New Class of Oral Treatments Known as DPP-4 Inhibitors, Recommended for Approval for the Treatment of Type 2 Diabetes in the European Union

01/25/2007

First New Prescription Smoking Cessation Treatment Approved in a Decade

01/24/2007

Lucentis(R) (Ranibizumab) Receives Approval in the European Union - The First Drug to Improve Vision in Patients With Wet AMD, a Leading Cause of Blindness

01/23/2007

Wyeth Receives Approvable Letter From FDA for Pristiq (Desvenlafaxine Succinate) for the Treatment of Major Depressive Disorder

01/23/2007

Stiefel Laboratories Receives FDA Approval of Olux-E (Clobetasol Propionate) Foam, 0.05% for Treatment of Psoriasis and Eczema

01/22/2007

Eisai Announces Inovelon(R) (Rufinamide) Receives Marketing Authorization Approval from European Commission

01/22/2007

FDA Grants Chelsea Therapeutics Orphan Drug Designation for Droxidopa

01/18/2007

FDA Approves 18-Month Shelf Life for Taxus(R) Stent System

01/18/2007

Cipralex Approved in Europe for Treatment of Obsessive Compulsive Disorder

01/17/2007

FDA Approves Lialda(TM) (Mesalamine), the First Oral Once-Daily Mesalamine For Patients With Active, Mild to Moderate Ulcerative Colitis

01/15/2007

Lux Biosciences Receives Orphan Drug Designation from the FDA for Two Ophthalmic Products

01/10/2007

Neorecormon Gains European Approval for Convenient Once Weekly Treatment of Anaemia in Patients With Solid Cancers

01/08/2007

FDA Approves MedImmune's Refrigerated Formulation of FluMist(R)

01/05/2007

Positive and Robust Phase 2 Results for Novel Sleep Drug - HY10275

01/05/2007

Correction of Dosing Chart for the Tamiflu Oral Suspension for Prophylaxis of Influenza in Pediatric Patients

01/03/2007

FDA Approves Byetta(R) (Exenatide) Injection for Expanded Combination Use

12/29/2006

Boca Pharmacal Receives FDA Approval for Generic Pamine(R) and Pamine(R) Forte Tablets

12/27/2006

FDA Approves Radiesse(R) Facial Filler for Two New Aesthetic Indications

12/21/2006

FDA Approves New Indication for Invanz(R) (Ertapenem) for the Prevention of Surgical Site Infections (SSI) following Elective Colorectal Surgery in Adults

12/20/2006

FDA Approves Treatment for Children and Teens With Mildly to Moderately Active Ulcerative Colitis

12/20/2006

Positive Opinion From European Regulatory Authorities for combination use of Actos® (Pioglitazone HCl) With Insulin for Type 2 Diabetes

12/20/2006

Invega(TM) (Paliperidone) Approved By FDA as New Treatment for Schizophrenia

12/20/2006

Study Shows Fentanyl Iontophoretic Transdermal System Rated Comparably as Method of Pain Control to IV Patient-Controlled Morphine After Total Hip Replacement

12/19/2006

FDA Proposes Labeling Changes to Over the Counter Pain Relievers

12/19/2006

Trillium's TTI-1612 product receives orphan drug designation in Europe and the United States

12/19/2006

FDA Grants Torisel NDA Priority Review Status

12/19/2006

FDA Warns of Safety Concern Regarding Rituxan in New Patient Population

12/18/2006

BioSante Pharmaceuticals Receives FDA Approval of Bio-E-Gel(R) (estradiol gel), To Be Marketed as Elestrin(TM)

12/18/2006

Celebrex (Celecoxib) Approved to Treat Juvenile Rheumatoid Arthritis

12/18/2006

FDA Approves Drug to Treat Cyanide Poisoning

12/18/2006

FDA Approves Foradil(R) Certihaler(TM) (Formoterol Fumarate Inhalation Powder)

12/15/2006

FDA Revises Labeling for Trasylol (Aprotinin Injection) to Strengthen Safety Warnings and Limit Usage of Drug to Specific Situations

12/15/2006

Genta Receives Non-Approvable Notice for Application of Genasense(R) (Bcl-2 Antisense) in Patients With Chronic Lymphocytic Leukemia

12/15/2006

New England Journal of Medicine Publishes Data from Pivotal Study of Avastin Plus Chemotherapy in Most Common Type of Lung Cancer

12/15/2006

New Drug Offers Promise as Single Treatment for HIV

12/15/2006

Multiple Myeloma Patients Respond to Retreatment with Velcade(R) (Bortezomib) for Injection

12/08/2006

FDA Approves Velcade(R) (Bortezomib) for Injection for Aggressive Form of Non-Hodgkin's Lymphoma

12/05/2006

Nasonex (Mometasone Furoate Monohydrate) Approved by Health Canada for Nasal Polyps

12/01/2006

Eligard(R) (leuprolide acetate) 6-Month Formulation Approved in Germany

11/30/2006

Solesta Receives Approval in Europe for Treatment of Fecal Incontinence

11/30/2006

Abraxis BioScience Receives FDA Approval for Ampicillin and Sulbactam for Injection, 15g, USP

11/28/2006

Solaraze(R) (Diclofenac Sodium)Receives Approval in Australia

11/23/2006

FDA Approves Betaseron(R) (Interferon beta-1b) for Use After the First Event Suggestive of Multiple Sclerosis

11/22/2006

Sprycel(TM) (Dasatinib) Approved in Europe -- The First Significant Advance for Treatment-Resistant Cml and Ph+ All Leukaemia Patients in 5 Years

11/21/2006

Byetta(R) (Exenatide) Approved for Treatment of Type 2 Diabetes by European Commission

11/21/2006

US FDA Grants Immtech's Oral Drug Candidate Pafuramidine (DB289) Orphan Drug Status for Treatment of PCP

11/14/2006

Abbott's Humira(R) (adalimumab) Receives FDA Approval for Inhibiting Structural Joint Damage and Improving Physical Function in Patients With Psoriatic Arthritis

11/10/2006

FDA Approves Mirapex (Pramipexole Dihydrochloride) for the Treatment of Moderate-to-Severe Primary Restless Legs Syndrome

11/08/2006

FDA Approves Ziana(TM) (Clindamycin Phosphate 1.2% and Tretinoin 0.025%) Gel for Acne

11/07/2006

Prexige (Lumiracoxib) Cleared for Approval in the European Union as a New Treatment Option for Patients Suffering From Osteoarthritic Pain

11/03/2006

NovaDel Pharma Receives FDA Approval of NitroMist(TM)

10/31/2006

Avanir Receives FDA Approvable Letter for Zenvia(TM) for the Treatment of Involuntary Emotional Expression Disorder

10/31/2006

Alpharma Receives FDA Approval for Kadian(R) (Morphine Sulfate) 80mg Capsules

10/25/2006

Tyzeka(TM) (Telbivudine) Approved By U.S. Food and Drug Administration as a New Treatment for Patients With Chronic Hepatitis B

10/24/2006

FDA Approves New Formulation for Nexium (Esomeprazole Magnesium)

10/23/2006

FDA Approves New Treatment for Allergies

10/23/2006

FDA Approves Noxafil(R) (Posaconazole) for Treatment of Oropharyngeal Candidiasis

10/23/2006

FDA Approves Desonate(TM) (Desonide) Gel 0.05% With Patented Hydrogel Technology for Treatment of Atopic Dermatitis

10/20/2006

FDA Approves Reyataz(R) (Atazanavir Sulfate) 300 mg Single Capsule Formulation in Combination Therapy for Adults With HIV-1 Infection

10/20/2006

FDA Approves Seroquel(R) (Quetiapine Fumarate) for Bipolar Depression Treatment

10/20/2006

Gleevec(R) (Imatinib Mesylate) Approved in US for Five Rare Life-Threatening Disorders With Limited Treatment Options

10/20/2006

FDA Approves Prescription Zaditor (ketotifen fumarate) Eye Drops for Over-the-Counter Relief From Itchy Eyes

10/20/2006

FDA Approves Anti-Psychotic Drug Risperidone for Use in Children Diagnosed With Autism

10/19/2006

FDA Approves Allegra(R) (fexofenadine hydrochloride) Oral Suspension for Treatment of Seasonal Allergy Symptoms and Chronic Idiopathic Urticaria

10/19/2006

FDA Expands Remicade(R) (Infliximab) Indication for Ulcerative Colitis: Biologic Maintains Long-Term Clinical Remission and Mucosal Healing

10/18/2006

FDA Approves New Treatment for Advanced Head and Neck Cancer

10/18/2006

FDA Approves Once-Daily Januvia(TM) (Sitagliptin Phosphate), the First and Only DPP-4 Inhibitor Available in the United States for Type 2 Diabetes

10/17/2006

FDA Approves Supplemental Use of NovoSeven(R) Coagulation Factor VIIa (Recombinant) for Treatment of Acquired Hemophilia

10/17/2006

Dusa Pharmaceuticals Reports Brazilian Regulatory Approval for Levulan (Aminolevulinic Acid Hcl) Topical Solution

10/13/2006

FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease

10/13/2006

FDA Approves Nexium for the Treatment of Zollinger-Ellison Syndrome

10/12/2006

FDA Approves Avastin(R) (Bevacizumab) in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer

10/10/2006

FDA Approves the First Drug to Treat Irritability Associated with Autism, Risperdal

10/06/2006

Suboxone(R) (Buprenorphine/Naloxone) Approved in European Union for Treatment of Opioid Dependence

10/05/2006

FDA Approves New Label for Vytorin(R) (Ezetimibe/Simvastatin)

10/05/2006

FDA Approves FluLaval(TM) (Influenza Virus Vaccine)

10/05/2006

FDA Approves New Indication for YAZ(R) (3 mg drospirenone/20 mcg ethinyl estradiol) to Treat Emotional and Physical Symptoms of Premenstrual Dysphoric Disorder

10/04/2006

Health Canada Grants Approval of Tysabri(TM) (Natalizumab) for the Treatment of Multiple Sclerosis Following Priority Review

10/04/2006

FDA Approves Atropine Treatment for Wider Usage

09/30/2006

FDA Approves Two New Indications for Rituxan(R) (Rituximab) in Patients With Non-Hodgkin's Lymphoma

09/29/2006

Lamictal (Lamotrigine) - Exposure to Medication During the First 3 Months of Pregnancy May Increase Chances of Baby Being Born With Cleft Lip or Cleft Palate

09/29/2006

Pfizer's Anti-Smoking Pill Champix(R) (Varenicline) Approved in Europe

09/29/2006

Labopharm Receives Approvable Letter From FDA for Once-Daily Tramadol

09/27/2006

FDA Approves Remicade(R) (Infliximab) for Treatment of Chronic Severe Plaque Psoriasis

09/26/2006

Cephalon Receives FDA Approval of Fentora(TM) (fentanyl buccal tablet) for the Management of Breakthrough Pain in Patients with Cancer

09/26/2006

Grazax(R) Tablet-Based Vaccine Against Grass Pollen Allergy Approved in Europe

09/26/2006

FDA/Genentech Warning on Avastin (Bevacizumab)

09/25/2006

FDA Approves New Epilepsy Indication For Lamictal(R) (Lamotrigine) Tablets

09/22/2006

European Commission Approves Gardasil(R) Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine, Merck's Cervical Cancer Vaccine

09/22/2006

CDC Recommends Routine, Voluntary HIV Screening in Health Care Settings

09/21/2006

FDA Warns of Serious Blood Clot Risk in Women on Ortho Evra (Norelgestromin/Ethinyl Estradiol)

09/21/2006

Exjade (Deferasirox), a Breakthrough Once-Daily Oral Iron Chelator, Now Available in the UK

09/21/2006

Telbivudine Approved in Switzerland for Chronic Hepatitis B

09/20/2006

FDA Approves Connetics' Verdeso Foam for the Treatment of Mild-to-Moderate Atopic Dermatitis

09/19/2006

Asthma Treatment Approved By Health Canada for Relief of Symptoms of Seasonal Allergic Rhinitis

09/19/2006

Glivec(R) (Imatinib) Receives Additional EU Approvals for Use in Treating a Rapidly Progressive Form of Leukemia and a Hard-to-Treat Solid Cancer Tumor

09/19/2006

Pfizer's Lyrica(R) (Pregabalin Capsules) Approved in Europe for Difficult-to-Treat Nerve Pain

09/18/2006

FDA Approves Noxafil(R) (Posaconazole) for Prevention of Invasive Fungal Infections

09/13/2006

Abraxane(TM) (Paclitaxel Powder for Injectable Suspension) Approved for Advanced Breast Cancer Treatment in Canada

09/13/2006

Health Canada-Approved Treatment Reduces Potentially Fatal Chemotherapy Side-Effect by as Much as 94%

09/07/2006

Orphan Designation Granted for Advexin Therapy in European Union

09/06/2006

Neuprex(R) (Opebacan) Granted Orphan Status in Europe in Meningococcal Disease

08/31/2006

Health Canada Approves SUTENT for Metastatic Kidney Cancer

08/30/2006

Mylan Announces Tentative Approval for Fluoxetine Capsules, USP

08/30/2006

Atrium Medical Corporation receives FDA approval for the iVENA(TM) Vascular Patch

08/28/2006

Hydralazine HCl Voluntary Recall Due to Particulates

08/28/2006

InSite Vision Announces FDA Acceptance of New Drug Application for Review

08/25/2006

Health Canada Endorsed Important Safety Information on Rapamune (Sirolimus)

08/24/2006

FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older

08/23/2006

FDA Approves Keppra(R) (Levetiracetam) as Adjunctive Therapy in the Treatment of Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

08/23/2006

Oral Rotavirus Gastroenteritis Vaccine Approved in Canada

08/21/2006

Glaxo Adds Strong Heart Risk Warning to ADHD Drug

08/21/2006

Health Canada Approves Azilect(R) (Rasagiline) for Parkinson's Disease

08/18/2006

Eli Lilly and Company Receives Approvable Letter From FDA for Arxxant(TM) (Ruboxistaurin Mesylate)

08/18/2006

Keppra(R) (Levetiracetam) Granted European Monotherapy Approval

08/17/2006

FDA Approves New Medical Use for Plavix (Clopidogrel Bisulfate)

08/16/2006

FDA Approves Baclofen for Spasticity in Multiple Sclerosis

08/14/2006

U.S. FDA Approves Actonel for Broader Use in Men With Osteoporosis

08/14/2006

FDA Expands Remicade(R) Psoriatic Arthritis Indication: Anti-TNF Shown to Inhibit Joint Damage and Improve Physical Function

08/11/2006

FDA Warns Three Firms to Stop Mass-Producing Unapproved Inhalation Drugs

08/10/2006

Biologic Enbrel(R) (Entanercept) Available in Easy-to-Use, Prefilled Syringe

08/10/2006

Dacogen(TM) (Decitabine) for Injection Receives U.S. Orphan Drug Designation for Patients With Acute Myeloid Leukemia

08/08/2006

MacuSight Announces FDA Acceptance of IND for Novel Ophthalmic Drug Candidate

08/08/2006

Januvia(TM) (Sitagliptin Phosphate) Receives Approval in Mexico

08/03/2006

Betaferon(R) (Interferon beta-1b) Approved in Canada for Treatment of the Earliest Stages of Multiple Sclerosis

08/03/2006

FDA Approves Influenza Vaccines to be Manufactured for Upcoming Flu Season

08/02/2006

European Commission Approves ATryn(R) (recombinant human antithrombin)

08/02/2006

Baxter Receives Health Canada Approval for Advate(R) [Antihemophilic Factor (Recombinant)

08/02/2006

FDA Approves Keppra(R) (Levetiracetam) Intravenous Formulation

07/31/2006

Novo Nordisk Receives Approval in EU for Use of NovoRapid(R) (Insulin Aspart) in Pregnancy

07/31/2006

Merck Announces FDA Acceptance of New Drug Application for MK-0431A, an Investigational Fixed Dose Combination of Januvia(TM) and Metformin for Type 2 Diabetes

07/31/2006

FDA Approves duetact(TM) (pioglitazone HCl and glimepiride) for the Treatment of Type 2 Diabetes

07/31/2006

Temodal (Temozolomide) Approved by Japan's Ministry of Health, Labor and Welfare for Patients With Malignant Gliomas

07/31/2006

Humira (Adalimumab) Receives FDA Approval for Treatment of Ankylosing Spondylitis

07/31/2006

Health Canada Approves First New Advanced Kidney Cancer Treatment in More Than a Decade

07/31/2006

Ovarian Cancer Drug Combination Identified at Rational Therapeutics Receives FDA Approval

07/31/2006

FDA Approves Supplemental New Drug Application for Antiviral Treatment Famvir(R) (Famciclovir)

07/31/2006

FDA Approves Xolegel(TM) Gel for Treatment of Seborrheic Dermatitis

07/31/2006

Glivec(R) (Imatinib) Receives Positive European Union Opinion for Treatment of Rare, Potentially Life-Threatening Cancers With Limited Treatment Options

07/28/2006

Cervical Cancer Vaccine Receives Positive Opinion From European Medicines Agency

07/27/2006

European Commission Grants Conditional Marketing Authorization To Pfizer's Sutent® (Sunitinib Malate)

07/27/2006

Vegamox(TM) (Moxifloxacin Hydrochloride Ophthalmic Solution) Approved in Japan for Eye Infections

07/27/2006

Patanol(R) (Olopatadine Hydrochloride Ophthalmic Solution), Approved in Japan for Allergic Conjunctivitis

07/27/2006

New Test Could Keep Babies From Contracting Deadly Infections

07/26/2006

FDA Grants Orphan Drug Designation to Allos Therapeutics' Novel Antifolate PDX (Pralatrexate) for Treatment of T-cell Lymphoma

07/25/2006

FDA Approves Oncaspar for Newly-Diagnosed Acute Lymphoblastic Leukemia

07/24/2006

Shire's Elaprase (Idursulfase) Approved by FDA for Hunter Syndrome

07/24/2006

First and Only Oral Medication Approved for Pulmonary Arterial Hypertension in HIV Patients

07/24/2006

Nexavar (Sorafenib) Approved by European Commission for the Treatment of Advanced Kidney Cancer

07/23/2006

Anti-EGFr Drug Nimotuzumab Approved in India for Head and Neck Cancer

07/22/2006

Liposome Vaccine Prostate Cancer Study Results Published

07/22/2006

Betamethasone Foam Demonstrates High Efficacy in Psoriasis Treatment and 85% Better Usability than Cream

07/22/2006

Nexavar (Sorafenib) Receives FDA Fast Track Designation for Skin Cancer

07/21/2006

FDA Approves Single-Rod Implantable Contraceptive

07/21/2006

Health Canada Approves First and Only Vaccine to Prevent Cervical, Vulvar and Vaginal Cancer as Well as Genital Warts

07/21/2006

Valeant Pharmaceuticals Announces Availability of Zelapar(R) for Parkinson's Disease Patients

07/21/2006

Nabi Biopharmaceuticals Releases New Data which Demonstrate Superior Serum Phosphorus Control with PhosLo® (calcium acetate) Over Sevelamer

07/21/2006

Cimzia Shows Promise in Treatment of Psoriasis

07/17/2006

FDA Approves Lilly's Gemzar (Gemcitabine HCl) for Ovarian Cancer Treatment

07/14/2006

Multiple Myeloma Oral Therapy Revlimid (Lenalidomide) Approved by FDA

07/13/2006

New UK Licence Indication for Arimidex (Anastrozole) Extends Benefits to More Adjuvant Patients With HR+ Early Breast Cancer

07/12/2006

U.S. FDA Approves Atripla (Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate), First Once-Daily Single Tablet Regimen for Adults With HIV-1 Infection

07/11/2006

Mabthera Approved for Use in Rheumatoid Arthritis in Europe

07/11/2006

Mabthera Approved in Europe for Maintenance Therapy in Patients With Common Form of Lymphoma

07/11/2006

FDA Approves Emend (Aprepitant), Merck's Antiemetic Therapy, for the Prevention of Postoperative Nausea and Vomiting

07/11/2006

FDA Approves Avandamet (Rosiglitazone Maleate and Metformin HCl) as Initial Therapy in the Treatment of Type 2 Diabetes

07/10/2006

European Commission Approves Revision of Therapeutic Indication for Rebif (interferon beta-1a)

07/07/2006

ZARS Pharma Announces FDA Approval of a Topical Local Anesthetic Peel (Lidocaine and Tetracaine) 7%/7%

07/04/2006

Health Canada Endorsed Important Safety Information on Anzemet (Dolasetron Mesylate)

07/03/2006

New Tablet Formulation of Kaletra (Lopinavir/Ritonavir) Approved in Europe

07/03/2006

FDA Grants Tentative Approval of a Three-Component AIDS Drug

06/30/2006

FDA Approves Lucentis for the Treatment of Wet Age-Related Macular Degeneration

06/30/2006

Revlimid in Combination With Dexamethasone sNDA Granted Approval By FDA for Treatment of Multiple Myeloma

06/30/2006

Cephalon Receives Approvable Letter for Fentora(TM) (fentanyl buccal tablet) for Management of Breakthrough Pain in Patients with Cancer

06/29/2006

FDA Approves Sprycel (Dasatinib) With Two Indications

06/29/2006

Tysabri (Natalizumab) Receives Approval in European Union for Treatment of Relapsing Remitting Forms of Multiple Sclerosis

06/29/2006

Wyeth Receives Approvable Letter From the FDA for Lybrel

06/28/2006

The U.S. Food and Drug Administration Approves Exelon(R) (rivastigmine tartrate) as the First Medication Indicated to Treat Parkinson's Disease Dementia

06/28/2006

EntreMed Granted Orphan Drug Designation for Panzem(R) (2ME2) In Glioblastoma

06/26/2006

Lupin Receives Final Approval for Quinapril Tablets

06/26/2006

FDA Approves First Generic Simvastatin

06/26/2006

FDA Approves New HIV Treatment for Patients Who Do Not Respond to Existing Drugs

06/23/2006

Genaera Receives Patent for Gene Variants of Interleukin-9 Receptor

06/23/2006

Penwest Announces That Endo Reports Receiving Final FDA Approval for Oxymorphone ER - Pain Relief Product Expected to Be Commercially Available in the U.S. in the Coming Weeks Under Trade Name Opana(R) ER -

06/23/2006

Endo Receives FDA Approval for Opana(R) ER (oxymorphone HCl) Extended-Release and Opana(R) (oxymorphone HCl) Immediate Release Tablets CII

06/21/2006

FDA Approves Avastin (Bevacizumab) in Combination With Chemotherapy for Second-Line Metastatic Colorectal Cancer Patients

06/21/2006

Elusys' Anthrax Therapeutic, Anthim, Granted FDA Orphan Drug Designation

06/16/2006

Baxter Receives Tentative FDA Approvals for Ondansetron Injection in Vials and Premix Containers

06/15/2006

Discovery Labs' Surfaxin Granted Orphan Drug Designation for the Prevention of Bronchopulmonary Dysplasia

06/15/2006

GlaxoSmithKline Announces Expanded Indication for Hycamtin (Topotecan HCl) to Treat Cervical Cancer in Combination Chemotherapy New Indication Based on Survival

06/14/2006

Health Canada Approves Treatment for Anemia-Related Fatigue in Chemotherapy Patients

06/14/2006

Pharming Receives Orphan Drug Designations for rhC1INH From U.S. FDA

06/13/2006

Vivitrol, the First, Once-Monthly Injectable Medication for Alcohol Dependence Now Available in the United States

06/13/2006

Nexavar Receives Fast Track Designation from the FDA for Metastatic Liver Cancer

06/13/2006

Saforis NDA Accepted by U.S. FDA for Priority Review

06/12/2006

FDA Approves the First Drug for Seasonal Depression

06/09/2006

Pozen Inc. and GlaxoSmithKline Report Receipt of Approvable Letter for Investigational Migraine Treatment

06/09/2006

FDA Approves New Indication for Zetia (Ezetimibe)

06/09/2006

Hana Biosciences Receives Orphan Drug Designation for Ropidoxuridine (IPdR), for the Treatment of Malignant Glioma

06/08/2006

Health Canada Approves Remicade (Infliximab) for Psoriasis and Psoriatic Arthritis

06/08/2006

FDA Approves Merck's Gardasil®, the World's First and Only Cervical Cancer Vaccine

06/07/2006

Betaferon (Interferon Beta-1b) Approved in Europe as a First-Line Treatment for the Earliest Stages of Multiple Sclerosis

06/07/2006

EU Approval Marks Third for Humira in Treating Autoimmune Diseases

06/06/2006

Alliant Pharmaceuticals Announces Return of Chewable Tablets for ADHD

06/06/2006

Aspreva and Roche Receive Orphan Drug Designation from FDA for Evaluation of CellCept in Rare Autoimmune Disease Pemphigus Vulgaris

06/06/2006

Xechem Receives Orphan Drug Designation From The FDA For Its Anti-Sickling Drug 5-HMF

06/06/2006

Health Canada Further Restricts the Indication of Iressa (Gefitinib) to Patients Currently Benefiting From Iressa Treatment and Whose Tumours Are EGFR Positive or Unknown

06/05/2006

FDA Approves Resumed Marketing of Tysabri (Natalizumab) Under Special Distribution Program

06/02/2006

BioMarin and Alliant Announce FDA Approval of Orapred ODT

06/02/2006

Preliminary Results from a Phase 3b Study Showed Patients With Wet AMD Treated With Ranibizumab Quarterly Experienced a 16-Letter Benefit Over the Control Group at 1 Year

06/01/2006

Astellas Launches Vesicare (Solifenacin Succinate) for Treatment of Overactive Bladder in Japan

06/01/2006

Isis Pharmaceuticals Receives Orphan Drug Status for ISIS 301012 for the Treatment of Homozygous Familial Hypercholesterolemia

06/01/2006

Evoltra (Clofarabine) Approved in Europe for Relapsed or Refractory Acute Lymphoblastic Leukaemia

05/31/2006

Updated Product Information for Efexor

05/31/2006

European Commission Grants Orphan Medicinal Product Designation to Increlex for the Treatment of Primary Insulin-Like Growth Factor-1 Deficiency

05/31/2006

Sandoz Gets Precedent-Setting US Approval for Omnitrope as First Follow-on Version of a Previously Approved Recombinant Biotechnology Drug

05/26/2006

New Cautions Regarding Rare Heart-Related Risks for All ADHD Drugs

05/26/2006

FDA Approves Expanded Label for IV Antibiotic Cubicin® (Daptomycin for Injection)

05/26/2006

Thalomid sNDA Granted FDA Approval For Treatment of Newly Diagnosed Multiple Myeloma

05/26/2006

FDA Approves Seasonique(TM) Extended-Cycle Oral Contraceptive

05/26/2006

FDA Licenses New Vaccine to Reduce Older Americans' Risk of Shingles

05/25/2006

Iplex Available in U.S. for Children With Severe Short Stature

05/25/2006

Allergan Receives Pan European License for Bimatoprost/Timolol Ophthalmic Solution From European Commission

05/25/2006

Health Canada Endorses Important Safety Information on Evista (Raloxifene Hydrochloride)

05/23/2006

CEL-SCI Presents Long-Term Survival Data With Its Anti-Cancer Drug

05/23/2006

ALZA Corporation Receives FDA Approval for Ionsys (Fentanyl Iontophoretic Transdermal System)

05/23/2006

Focalin XR Receives FDA Approval of New Labeling Information in Attention-Deficit/Hyperactivity Disorder

05/22/2006

FDA Approves Remicade (infliximab) as First and Only Biologic Treatment for Children With Active Crohn's Disease

05/19/2006

Spectrum Laboratory Products Recalls Tacrolimus Active Pharmaceutical Ingredient [API]

05/19/2006

Parkinson's Drug Receives FDA Approval

05/19/2006

First Over-the-Counter Migraine Pill Available in UK

05/18/2006

Bristol-Myers Squibb Announces Discontinuation of Development of Muraglitazar, an Investigational Oral Treatment for Type 2 Diabetes

05/17/2006

FDA Approves Azilect (Rasagiline Tablets) for Parkinson's Disease

05/17/2006

Updated safety information for Tequin (Gatifloxacin) and Serious Hypoglycemia and Hyperglycemia

05/17/2006

Coley's Actilon for Chronic Hepatitis C Virus Therapy Granted

05/17/2006

Exemestane Becomes the First And Only Aromatase Inhibitor for Adjuvant Sequential Therapy in Early-Stage Breast Cancer

05/17/2006

New Long-Acting Insulin Analog Levemir (Insulin Detemir [rDNA Origin] Injection) Available in United States

05/16/2006

Valeant Receives FDA Marketing Approval for Cannabinoid Cesamet(TM) (CII)

05/16/2006

Neurocrine Receives Approvable Letter for Indiplon Capsules and Non-Approvable for Indiplon Tablets for Treatment of Insomnia

05/15/2006

Advancis Pharmaceutical Receives FDA Approval Letter for New Strengths of Antibiotic Keflex(R)

05/12/2006

One Lot of Minitran Transdermal System 0.6 Mg/Hr (Nitroglycerin) Recalled By Manufacturer

05/12/2006

Changes to Warnings on Paroxetine

05/11/2006

WHO Announces Pharmaceutical Companies Agree to Stop Marketing Single-Drug Artemisinin Malaria Pills

05/11/2006

FDA Approves Novel Medication for Smoking Cessation

05/10/2006

Boston Scientific and BioForm Medical Announce FDA Approval of Injectable Implant

05/10/2006

Green Light in Europe for Schering's New Low-Dose Contraceptive

05/10/2006

Cell Genesys Receives Fast Track Status for Immunotherapy for Prostate Cancer

05/09/2006

Lilly Submits Supplemental New Drug Application for Generalized Anxiety Disorder

05/08/2006

Introgen's Advexin p53 Therapy Provided to Cancer Patients With Li-Fraumeni Syndrome

05/08/2006

Roche Releases Guidelines for Consumers on How to Avoid Counterfeit Flu Drug

05/08/2006

Femara Endorsed Post-Surgery for Women With Early Breast Cancer in Scotland

05/08/2006

Duramed's Enjuvia (Synthetic Conjugated Estrogens, B) Now Available in U.S. Pharmacies

05/05/2006

USAN Council Approves Nonproprietary Name Lorcaserin Hydrochloride for Arena Drug Candidate APD356

05/04/2006

Pfizer's Genotropin (Somatropin [rDNA origin] for Injection) Approved in The U.S. for Treatment of Growth Failure Associated With Turner Syndrome

05/03/2006

GSK Receives Positive Opinion From CHMP on Seretide (Salmeterol/Fluticasone Propionate) Dosing for Initial Maintenance Therapy

05/03/2006

U.S. FDA Approves Dacogen (Decitabine) for Injection

05/02/2006

New Broad-Spectrum Antibiotic Tygacil (Tigecycline) Receives Approval for Use in Europe

05/02/2006

Novo Nordisk Receives EU Approval for NovoMix® 30 (Biphasic Insulin Aspart) Label Extension

05/01/2006

Intravenous Form and Labeling Approved for Ibandronate: Presented at AACE

04/28/2006

FDA Approves Genzyme's Myozyme (Alglucosidase Alfa) for All Patients with Pompe Disease

04/28/2006

SkyePharma Announces First European Approval of DepoDur

04/28/2006

Acomplia (Rimonabant) Recommended for Approval in the European Union

04/28/2006

CHMP Issues Positive Opinion for Tysabri (Natalizumab) as a Treatment for Relapsing-Remitting Multiple Sclerosis

04/28/2006

Herceptin Receives Positive Opinion in Europe for Early Use in HER2-Positive Breast Cancer

04/28/2006

Nexavar Receives Positive Opinion from European Committee for Medicinal Products for Human Use

04/28/2006

Humira (Adalimumab) Receives Positive Opinion From European Medicines Agency for the Treatment of Ankylosing Spondylitis

04/28/2006

Pfizer's Sutent Receives Positive Opinion in the European Union For Two Difficult-To-Treat Advanced Cancers

04/28/2006

New Tablet Formulation of Kaletra (Lopinavir/Ritonavir) Receives Positive Opinion From the European Medicines Agency

04/27/2006

Astellas Launches Vaprisol for Treatment of Euvolemic Hyponatremia in Hospitalized Patients

04/26/2006

FDA Grants Orphan Drug Designation to Nexavar (Sorafenib) for the Treatment of Hepatocellular Carcinoma

04/26/2006

European Commission Issues Marketing Authorization for Preotact (Parathyroid Hormone for Injection)

04/26/2006

Depomed and Esprit Announce Availability of ProQuin XR (Ciprofloxacin Hydrochloride) 3-Tablet Blister Packs

04/26/2006

EU Label Change for Intron A (Interferon Alfa-2b) Incorporates Long-Term Efficacy Data in Patients with Chronic Hepatitis C

04/25/2006

Astex Therapeutics Announces IND Approval For Novel Cancer Drug AT9283

04/25/2006

Amitiza (Lubiprostone), the First Selective Chloride Channel Activator for the Treatment of Chronic Idiopathic Constipation, Launches in the United States

04/24/2006

Higher Dose Copegus (Ribarivin) 400mg Tablets Approved in the Netherlands as First Step to European Availability

04/20/2006

AEterna Zentaris Gains Market Approval for Cetrotide (cetrorelix) in Japan for In Vitro Fertilization

04/20/2006

FDA Grants Fast Track Designation to Schering-Plough for its Thrombin Receptor Antagonist

04/19/2006

New Oral Contraceptive Available in the United States

04/18/2006

European Commission Grants Orphan Medicinal Product Designation to Nexavar for the Treatment of Hepatocellular Carcinoma

04/18/2006

Neurochem announces eprodisate (Fibrillex) NDA filed and granted priority review by FDA for the treatment of AA amyloidosis

04/18/2006

TheraQuest Receives FDA Fast Track Designation for Tramadol ER in Painful HIV-associated Neuropathy

04/11/2006

European Regulatory Committee Recommends Orphan Medicinal Product Designation for Amigal (migalastat hydrochloride) for Fabry Disease

04/10/2006

Euflexxa Labeling Extended to Include Room Temperature Storage

04/10/2006

FDA Grants Priority Review of Remicade for Treatment of Children With Active Crohn's Disease

04/07/2006

Adartrel (Ropinirole) Becomes First RLS Treatment to Receive Positive Decision From the European Commission

04/07/2006

Shire's Daytrana Transdermal Patch Approved by FDA for Treatment of ADHD

04/07/2006

Boehringer Ingelheim's Sifrol/Mirapexin (Pramipexole) First Treatment for Restless Legs Syndrome to Be Approved Throughout European Union

04/04/2006

Avanir's Neurodex NDA Accepted with Priority Review for Involuntary Emotional Expression Disorder

04/04/2006

FDA Grants Priority Review of Remicade (Infliximab) for the Treatment of Children with Active Crohn's Disease

04/04/2006

Cephalon Oncology Compound Lestaurtinib (CEP-701) Granted Orphan Drug Designation for Acute Myeloid Leukemia

04/04/2006

Samaritan's Marketing Authorization Application for Amphocil Approved in Greece

04/04/2006

FDA Grants Edison's EPI-A0001 Orphan Drug Designation for Inherited Mitochondrial Respiratory Chain Diseases

04/03/2006

European Commission Approves First Treatment for Pompe Disease

04/03/2006

Taclonex New Dual-Action Topical Therapy for Plaque Psoriasis Now Available for Prescription

03/31/2006

Prestwick Pharmaceuticals Receives FDA Approvable Letter for Xenazine (Tetrabenazine) for Treatment of Chorea Associated with Huntington's Disease

03/31/2006

Roche Says E.U. Approves Bonviva (Ibandronate) as Quarterly Treatment

03/31/2006

FDA Approves Prograf (Tacrolimus) to Prevent Rejection of Heart Transplant

03/30/2006

First Biologic Therapy Approved in Canada for Painful Inflammatory Bowel Disease

03/30/2006

PTC Therapeutics Receives Fast Track Designation for PTC124 in the Treatment of Duchenne Muscular Dystrophy

03/30/2006

Nexavar Approved in Switzerland for the Treatment of Patients with Advanced Kidney Cancer

03/29/2006

Innovative Osteoporosis Treatment, Fosavance, Integrates Two Essential Elements of Treatment -- Medication and Vitamin D in a Single Once-Weekly Tablet

03/29/2006

FDA Approves a Second Drug for the Prevention of Influenza A and B in Adults and Children

03/28/2006

Health Canada Approves Xeloda (Capecitabine) for Adjuvant Therapy in the Treatment of Colon Cancer

03/28/2006

Cephalon Granted Six Months of Pediatric Exclusivity for Provigil (Modafinil)

03/27/2006

Santarus Receives FDA Approval for Zegerid With Magnesium Hydroxide Chewable Tablets

03/27/2006

Crucell Announces Product Approval in Korea for Quinvaxem Vaccine

03/27/2006

European Medicines Agency Recommends Cautious Use of Protopic/Protopy and Elidel

03/27/2006

FDA Approves Extended Dosing of Aranesp (Darbepoetin Alfa) to Treat Chemotherapy-Induced Anemia

03/27/2006

Pfizer's Lyrica (Pregabalin) Approved for Treatment of Generalized Anxiety Disorder (GAD) in Europe

03/24/2006

Allergan Receives Positive Opinion for Ganfort (Lumigan/Timolol Combination) in European Union

03/24/2006

New Dosages of Risperdal (Risperidone) Now Available

03/24/2006

FDA Advisory Committee Recommends Against Approval of Sparlon for Attention Deficit/Hyperactivity Disorder in Children and Adolescents

03/23/2006

Taxotere (Docetaxel) Receives U.S. FDA Approval For Use In Advanced Stomach Cancer

03/23/2006

Aastrom Biosciences Receives Orphan Drug Designation from the FDA for Proprietary Bone Marrow Cells

03/23/2006

Pharmaxis' First Product, Aridol, Approved by Therapeutic Goods Administration

03/23/2006

Remicade Approved in Australia for Treatment of Early Rheumatoid Arthritis and Psoriatic Arthritis

03/23/2006

FDA Approves Flovent HFA (fluticasone propionate HFA) Inhalation Aerosol for Children Four to Eleven

03/22/2006

Study Shows Levitra Treats Erectile Dysfunction Effectively in Men Taking Medications to Lower High Blood Pressure

03/22/2006

Pixantrone Combination Regimen Produces High Rates of Complete Remission for Patients With Aggressive NHL Who Fail CHOP Therapy

03/22/2006

Avicena Compound Receives Orphan Drug Designation for Huntington's Disease

03/21/2006

FDA Approves Expanded Label Indication and Satisfaction of Subpart H Accelerated Approval Commitment for Remodulin (Treprostinil Sodium) Injection

03/20/2006

Femara (letrozole) Approved in Germany as Initial Therapy for Postmenopausal Women With Early Breast Cancer After Surgery

03/17/2006

FDA Approves YAZ(R), the First Oral Contraceptive to Offer Drospirenone in a 24-Day, Active-Pill Regimen

03/16/2006

Phase 1/2 Clinical Data Demonstrate Safety and Antitumor Activity of Introgen's Advexin in Patients With Advanced Esophageal Cancer

03/16/2006

Chiron Recalls and Withdraws Morupar(R) MMR Vaccine from Italian and Developing World Markets

03/16/2006

Myriad Genetics' Follow-on Study of Flurizan Demonstrates Continued Benefit in Alzheimer's Disease

03/15/2006

Up to Half of Metabolic Improvement Seen With Rimonabant Is Attributable to Drug Rather Than Weight-Loss Alone: Presented at ACC

03/15/2006

Roche Canada resumes Tamiflu distribution

03/15/2006

Novo Nordisk Receives Positive Opinion for Label Extension for Novomix 30 in Europe

03/10/2006

NPS Receives Approvable Letter for PREOS New Drug Application

03/10/2006

Advisory - Newer Antidepressants Linked to Serious Lung Disorder in Newborns

03/09/2006

Gliadel Wafer Demonstrates Long-Term Survival Benefit for Patients With High-Grade Malignant Gliomas

03/09/2006

Remicade Is First Biologic Approved in European Union to Treat Ulcerative Colitis

03/08/2006

U.S. FDA Grants Traditional Approval for Gilead's Once-Daily HIV Medications Truvada (emtricitabine and tenofovir disoproxil fumarate) and Viread (tenofovir disoproxil fumarate)

03/08/2006

Exelon granted EU marketing authorization as first treatment for dementia associated with Parkinson's disease by European Commission

03/02/2006

Wyeth Pharmaceuticals' Antibiotic Tygacil (Tigecycline) Receives 'Positive Opinion' From European Regulatory Authority

03/02/2006

FDA MedWatch - Tracleer (Bosentan): Recommended Dosage Adjustment and Monitoring Guidelines to Avoid Hepatotoxicity

03/02/2006

FDA Approves Erbitux (Cetuximab), First Head & Neck Cancer Treatment in 45 Years

03/02/2006

FDA MedWatch - Cefazolin for Injection Recalled Due to Microbial Contamination of Active Ingredient

03/01/2006

FDA Approves Rituxan (Rituximab), the First Targeted B-Cell Therapy for Treatment of Moderate-to-Severe Rheumatoid Arthritis

02/28/2006

Bayer Issues Letter to Health Care Professionals in Canada Regarding Trasylol (Aprotinin)

02/28/2006

Santarus Receives FDA Approval for Zegerid Capsules; First and Only Immediate-Release Proton Pump Inhibitor in Convenient Capsule Form

02/28/2006

FDA Approves Emsam (selegiline transdermal system), the First Transdermal Patch for the Treatment of Major Depressive Disorder

02/27/2006

Rotarix: First Vaccine Against Rotavirus Available in Europe

02/27/2006

Novartis Receives Approvable Letter from FDA for Aclasta (Zoledronic Acid 5 mg) in Treatment of Paget's Disease of the Bone

02/27/2006

Novartis Receives Approvable Letter from FDA for Aclasta (Zoledronic Acid 5 mg) in Treatment of Paget's Disease of the Bone

02/24/2006

Alcon Receives Positive Opinion for DuoTrav Eye Drops Solution from CHMP

02/24/2006

Clofarabine Receives Positive Opinion From European Medicines Agency

02/23/2006

CHMP Recommends Authorization to Market Preotact (PREOS) in Europe

02/23/2006

Otsuka Maryland Research Institute, Inc. Granted Fast Track Designation for Tolvaptan in Polycystic Kidney Disease

02/23/2006

Merck KGaA Receives EMEA Positive Opinion for Erbitux in Head and Neck Cancer Recommending Approval in the EU

02/22/2006

Clinical Data Receives FDA 510(k) Clearance for Nanopia Wide Range CRP Assay

02/22/2006

Progenics Pharmaceuticals' HIV Drug, PRO 140, Receives FDA Fast-Track Designation

02/21/2006

Once Daily Ultram ER Extended-Release Tablets Now Available in the United States

02/21/2006

Pfizer Receives FDA Approval for Eraxis (Anidulafungin) to Treat Candidemia, a Potentially Life-Threatening Bloodstream Infection

02/21/2006

Viragen's Multiferon Approved in Sweden for First-Line Adjuvant Treatment of Malignant Melanoma

02/20/2006

FDA Approves New Oral Contraceptive Loestrin 24 Fe (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets)

02/20/2006

Sanofi-aventis Received from the FDA an Approvable Letter for Rimonabant for Weight Management and a Non Approvable Letter for Smoking Cessation

02/17/2006

Health Canada Advises Diabetic Patients Not to Use the Antibiotic Tequin (Gatifloxacin)

02/17/2006

Alvesco (Ciclesonide) Additionally Approved for Adolescents in Europe for All Severities of Persistent Asthma

02/16/2006

Stronger Warnings for Tequin (gatifloxacin)

02/16/2006

FDA Alerts Healthcare Professionals About Nimodipine (Nimotop) Boxed Warning

02/15/2006

Risk of Serious Harm and/or Death With Potential IV/SC Administration of Fluphenazine Due to Mislabelled Octreotide Vials

02/15/2006

Tysabri Multiple Sclerosis Clinical Trial Hold Lifted by FDA; Biogen Idec and Elan to Resume Clinical Trial Dosing in Multiple Sclerosis

02/15/2006

Amicus Therapeutics' AT2101 Granted Orphan Drug Designation for the Treatment of Gaucher Disease

02/14/2006

Caduet (Amlodipine Besylate/Atorvastatin calcium), First Pill to Treat High Blood Pressure and High Cholesterol at the Same Time

02/14/2006

AstraZeneca Decides to Withdraw Exanta (Melagatran/Ximelagatran)

02/14/2006

TolerRx Receives Orphan Drug Designation from FDA for TRX4 for Treatment of New-Onset Type 1 Diabetes

02/14/2006

FDA Grants Orphan Drug Designation to First Amphotericin B Inhalation Powder to Prevent Pulmonary Fungal Infections in Immunosuppressed Patients

02/13/2006

FDA-Requested Recall of Cytosol Laboratories' Balanced Salt Solution Due to Dangerous Levels of Endotoxin

02/13/2006

FDA Issues Public Health Advisory About Benzocaine Sprays

02/13/2006

Morphotek Announces FDA Acceptance of the IND for MORAb-009, a Monoclonal Antibody for the Treatment of Mesothelin-Expressing Cancers

02/13/2006

YM BioSciences Receives FDA Fast Track Designation for Tesmilifene in Advanced Breast Cancer

02/10/2006

FDA Approves Rituxan (Rituximab) Plus CHOP or Other Anthracycline-Based Chemotherapy Regimens for First-Line Treatment of Diffuse Large B-cell Non-Hodgkin's Lymphoma

02/09/2006

Health Canada Approves Enbrel (Etanercept) for Psoriasis treatment

02/08/2006

FDA Issues Public Health Advisory for Trasylol (Aprotinin Injection)

02/08/2006

New Long-Acting Insulin, Levemir, Shows Less Weight Gain Associated With Insulin Therapy - Now Available In Canada

02/08/2006

Xyotax (Paclitaxel Poliglumex) has FDA Fast Track Designation for Women With Advanced Lung Cancer Who Are Performance Status 2

02/07/2006

Class 2 Medicines Recall for Nitrocine

02/07/2006

Antibiotic Ketek (Telithromycin) and Possible Association With Liver Failure

02/07/2006

FDA Grants Fast Track Status for ViroPharma's Maribavir for Prevention of Cytomegalovirus Infection

02/06/2006

TheraQuest's Abuse Deterrent Tramadol ER IND for Neuropathic Pain Accepted by FDA

02/03/2006

FDA Approves Merck's Rotateq, the Only Vaccine in the U.S. to Prevent Rotavirus Gastroenteritis, a Leading Cause of Severe Infant Diarrhea

02/03/2006

UCB Receives EMEA Positive Opinion and FDA Approvable Letter for Keppra (levetiracetam) Intravenous Administration

02/02/2006

OSI Pharmaceuticals Announces European Regulatory Approval for Macugen (Pegaptanib Sodium Injection); First Treatment for Neovascular (Wet) Age-related Macular Degeneration

02/02/2006

FDA Approves New Formulation of Imitrex (Sumatriptan Succinate) Injection

02/02/2006

FDA Grants Fast Track Designation for the Investigation of Zactima (ZD6474) for Treatment of Thyroid Cancer

02/02/2006

Nabi Biopharmaceuticals Announces U.S. Fast Track Designation for Civacir to Prevent Hepatitis C Re-infection in Liver Transplants

02/02/2006

Health Canada Approves Temodal (Temozolomide) for Patients With Newly Diagnosed Glioblastoma Multiforme

02/02/2006

FDA Approves Clarinex-D 12 Hour (Desloratadine/Pseudoephedrine) Tablet Prescription Antihistamine with Decongestant for Seasonal Allergy Sufferers

02/01/2006

European Commission Approves IV Hycamtin (Topotecan Powder for Concentrate for Solution for Infusion) for Relapsed Small Cell Lung Cancer

02/01/2006

Genzyme Granted Label Change for Thyrogen

02/01/2006

ActivBiotics Receives FDA Fast Track Status for Rifalazil in Peripheral Arterial Disease

02/01/2006

GlaxoSmithKline Announces the Approval and Availability of Avandaryl(TM) (Rosiglitazone Maleate and Glimepiride)

02/01/2006

FDA Approves Ranexa (Ranolazine) for Chest Pain

01/31/2006

FDA Approves New Prescription Drug for Adults for Treatment of Chronic "Idiopathic" Constipation

01/31/2006

FDA Requests Nimodipine (Nimotop) Label Change

01/31/2006

Tamiflu Gains Approval in Europe for Prevention of Influenza in Children Aged 1 to 12 Years

01/31/2006

U.S. FDA Approves Cangene's Anti-hepatitis B Product

01/31/2006

Schering-Plough Reports FDA Grants Fast Track Designation to Oral HCV Protease Inhibitor SCH 503034

01/31/2006

BioMarin Receives Marketing Approval for Naglazyme in European Union

01/30/2006

European Commission Approves Ionsys (Fentanyl HCl Iontophoretic Transdermal System) for Acute Post-operative Pain

01/30/2006

European Union's CHMP Recommends Approval of Exelon (Rivastigmine Tartrate) as First Symptomatic Treatment of Mild to Moderately Severe Dementia Associated With Idiopathic Parkinson's Disease

01/30/2006

European Union CHMP Recommends Approval of Remicade for Treatment of Moderately to Severely Active Ulcerative Colitis

01/30/2006

ISTA Pharmaceuticals Receives FDA Approval for Expanded Indication of Xibrom to Treat Pain Following Cataract Surgery

01/27/2006

FDA Approves Exubera (inhaled human insulin), First Ever Inhaled Insulin Combination Product for Treatment of Diabetes

01/27/2006

European Positive Opinion For First Quarterly I.V. Injection For Postmenopausal Osteoporosis

01/27/2006

Pfizer's Lyrica Receives Positive Opinion From CHMP for the Treatment of Generalized Anxiety Disorder in Adults

01/27/2006

Health Canada Warns Consumers of Recall of Octreotide Acetate Omega 500 mcg/mL Due to Possible Mislabelling

01/27/2006

Myozyme Receives Positive Opinion from European Regulatory Committee

01/27/2006

Association of WinRho SDF (Rho[D] Immune Globulin [Human]) with Intravascular Hemolysis in the treatment of Immune Thrombocytopenic Purpura

01/27/2006

Orphan Drug Designation Granted by European Commission for Anticancer Monoclonal Antibody 1D09C3 for Chronic Lymphocytic Leukemia

01/26/2006

Baxter Receives Marketing Authorization From the European Commission for Kiovig to Treat Immunodeficiencies

01/26/2006

FDA Approves Sutent (sunitinib) for Gastrointestinal and Kidney Cancer

01/26/2006

European Commission Approves Exubera (Inhaled Human Insulin) for Treatment of Type 1 and Type 2 Diabetes

01/26/2006

BioMarin Receives FDA Fast Track Designation for Phenoptin (Sapropterin Dihydrochloride) for Phenylketonuria

01/26/2006

FDA Grants Discovery Labs' Surfaxin Fast Track Designation for Prevention and Treatment of Bronchopulmonary Dysplasia

01/25/2006

FDA Clarifies Status of YAZ Premenstrual Dysphoric Disorder Application

01/24/2006

Pfizer's Somavert Available for Treatment of Acromegaly

01/24/2006

Serono's Gonal-f Approved in Japan for the Treatment of Male Hypogonadotropic Hypogonadism

01/24/2006

FDA Joint Advisory Committee Recommends Approval of Orlistat 60 mg Capsules for Over-the-Counter Use

01/23/2006

FDA Public Health Advisory: Ketek (Telithromycin) Tablets

01/23/2006

Nuvelo Receives FDA Fast Track Status for Alfimeprase

01/23/2006

Vion Pharmaceuticals Receives Orphan Drug Designation for Cloretazine (VNP40101M) in Europe for Treatment of Acute Myeloid Leukemia

01/19/2006

FDA Approves Updated Labeling with Boxed Warning and Medication Guide for Two Eczema Drugs, Elidel and Protopic

01/18/2006

FDA Announces New Prescription Drug Information Format to Improve Patient Safety

01/18/2006

Letter Warns of Hepatitis B Reactivation Associated with Anti-TNF alpha Products

01/18/2006

FDA Grants Priority Review to Plavix (Clopidogrel Bisulfate) Supplemental New Drug Application for Additional Type of Heart Attack

01/17/2006

Biovail Receives Approval for Wellbutrin XL to Treat Depression in Canada

01/17/2006

BioCryst Receives FDA Fast Track Designation for Peramivir

01/13/2006

FDA Warns Consumers about Brazilian Diet Pills Found to Contain Active Drug Ingredients

01/13/2006

Draxis Receives FDA Approval for Diagnostic Iodine I-131 Capsules

01/13/2006

Cipher receives FDA approval for Lipofen (CIP-Fenofibrate)

01/12/2006

Favrille Receives FDA Fast Track Designation for FavId, Lead Product Candidate for Follicular B-Cell Non-Hodgkin's Lymphoma

01/11/2006

Israeli Ministry of Health Approves Intravenous Dosing of Remodulin(R) to Treat Pulmonary Arterial Hypertension

01/10/2006

FDA Approves Taclonex (Calcipotriene/Betamethasone Dipropionate), Once Daily Therapy for Treatment of Psoriasis

01/10/2006

FDA Approves First Immune Globulin for Subcutaneous Use

01/09/2006

FDA Approves First IV Treatment for Postmenopausal Osteoporosis, Boniva (Ibandronate Sodium) Injection

01/06/2006

Drug Warning on Rho(D) Intravenous Human Immune Globulin (WinRho SDF)

01/04/2006

FDA Clears Xoft's Axxent Electronic Brachytherapy System for Treatment of Breast Cancer

01/04/2006

FDA Approves Once-a-Week Osteoporosis Hormone Therapy Patch Climara Pro (Estradiol/Levonorgestrel)

01/03/2006

Genmab's Humax-EGFr Awarded Fast Track Status from FDA

01/03/2006

Aspreva and Roche Receive Orphan Drug Designation from FDA for Evaluation of CellCept (Mycophenolate Mofetil) in Myasthenia Gravis

12/30/2005

FDA Approves Astellas' Vaprisol for Treatment of Euvolemic Hyponatremia

12/29/2005

U.S. FDA Approves Orencia (Abatacept) for Treatment Of Rheumatoid Arthritis

12/29/2005

Femara(R) Receives US Approval as Initial Therapy for Postmenopausal Women With Early Breast Cancer After Surgery

12/29/2005

Bristol-Myers Squibb Submits New Drug Application for Dasatinib

12/28/2005

FDA Approves New Treatment for Myelodysplastic Syndrome

12/28/2005

New Drug Application for Investigational HIV Protease Inhibitor TMC114 Submitted to US Food & Drug Administration

12/28/2005

New Drug Approved for Blood Disorder Also Demonstrates Positive Results in Myeloma Clinical Trials

12/28/2005

FDA Grants REVLIMID(R) NDA Approval

12/23/2005

STAAR Surgical's VISIAN ICL(TM) Receives FDA Approval

12/23/2005

An Association Between Avandia® and Avandamet® and Vision Problems in Diabetics

12/22/2005

U.S. Food and Drug Administration Extends Prophylaxis Indication for Tamiflu(R) to Children Ages 1 to 12

12/22/2005

Schering-Plough Announces PEG-Intron and Rebetol Approved in Japan for Expanded Use in Treating Chronic Hepatitis C

12/21/2005

Association of Tequin(Gatifloxacin) With Serious Hypoglycemia And Hyperglycemia

12/20/2005

FDA Approves Nexavar (Sorafenib) for Treatment of Patients with Advanced Kidney Cancer

12/19/2005

FDA Issues Public Health Advisory on use of NeutroSpec (Technetium [99m TC] Fanolesomab), Imaging Agent for Diagnosis of Appendicitis

12/16/2005

FDA Rules Anthrax Vaccine Safe and Effective to Prevent Anthrax Regardless of Route of Exposure

12/16/2005

FDA Notifies Health Care Professionals of Problem with Baxter Healthcare's Meridian Hemodialysis Instrument Kinks in Device Tubing Can Pose Serious Risk to Patients

12/16/2005

Health Canada Prohibits Sale of Bextra in Canada

12/13/2005

FDA Approves Insmed's Orphan Drug, Iplex (mecasermin rinfabate [rDNA origin] injection), for Treatment of Severe Primary IGF-1 Deficiency

12/13/2005

Alcon Receives Approval of Retaane Suspension (Anecortave Acetate Suspension) in Australia

12/12/2005

Cethrin Receives Orphan Drug Status

12/12/2005

Association of Severe Mucocutaneous Reactions with the Zevalin Therapeutic Regimen

12/12/2005

FDA issues an Alert and Patient and Healthcare Professional Sheets for Clarithromycin (Biaxin)

12/09/2005

FDA Advising of Risk of Birth Defects with Paxil

12/08/2005

Femara (Letrozole) Approved for Early Invasive Breast Cancer Post-Surgery

12/07/2005

Abbott's Depakote ER (Divalproex Sodium Extended-Release Tablets) Approved for Acute Manic or Mixed Episodes Associated With Bipolar Disorder

12/06/2005

FDA Warns Consumers about Unapproved and Bacterially-Contaminated Miracle II Neutralizer and Miracle II Neutralizer Gel Drug Products

12/06/2005

Health Canada Approves Lipitor (Atorvastatin Calcium) to Reduce Risk of Heart Attack and Stroke for People with Diabetes

12/05/2005

Approval Marks the First Recombinant Human Hyaluronidase Approved for Use as an Adjuvant Drug to Increase the Absorption and Dispersion of Other Injected Drugs

12/05/2005

Reports of Serious and Life-threatening Cardiopulmonary Events with Imaging Agent NeutroSpec (Technetium [99m Tc] fanolesomab)

12/02/2005

Amgen Updates Product Prescribing Information for Aranesp (darbepoetin alfa)

12/02/2005

Novo Nordisk Changes Labeling for NovoSeven Coagulation Factor VIIa (Recombinant)

12/01/2005

FDA Sends Out Alert about Alemtuzumab (Campath)

11/30/2005

Zydena (Udenafil), a New Erectile Dysfunction (ED) Drug, Receives Marketing Approval in Korea

11/30/2005

FDA Approves New Indication for Avelox (moxifloxacin HCl) for Treatment of Complicated Intra-Abdominal Infections

11/28/2005

Contraindication of Femara (Letrozole) in Premenopausal Women

11/28/2005

POZEN Receives Approval for MT 100 in the United Kingdom

11/28/2005

Solvay Pharmaceuticals Completes Market Authorization in 28 European Countries for Duodopa, its Treatment for Advanced Parkinson's Disease

11/24/2005

Effexor XR Approved in Canada for Symptomatic Relief of Panic Disorder

11/24/2005

FDA Issues Approvable Letter in Response to Application for Use of Fuzeon® with Needle-Free Injection Device

11/23/2005

Xyrem (Sodium Oxybate) Receives FDA Approval for the Treatment of Excessive Daytime Sleepiness in Patients with Narcolepsy

11/21/2005

Effexor XR (venlafaxine HCl) Approved for Treatment of Panic Disorder

11/18/2005

FDA Has Public Health Advisory on Inhaled Long-acting Bronchodilator Drugs

11/17/2005

First Oncolytic Viral Therapy Approved for Head and Neck Cancer

11/17/2005

Labopharm's Once-Daily Tramadol Product Launched in Germany

11/16/2005

Procoralan (Ivabradine), the First Pure Heart Rate-Lowering Agent, Receives Marketing Authorization in Europe

11/15/2005

MediGene's Drug Eligard Launched in Spain and Further European Countries

11/14/2005

Bronchitol Granted Orphan Drug Status in Europe

11/14/2005

Ferring Pharmaceuticals Announces Launch of Euflexxa for Osteoarthritis Knee Pain

11/14/2005

FDA Approves New Indication for Invanz (Ertapenem) for Treatment of Moderate to Severe Complicated Foot Infection in Diabetic Patients without Osteomyelitis

11/11/2005

Solbec's Coramsine Receives Orphan Drug Designation from the FDA

11/11/2005

FDA Updates Labeling for Ortho Evra Contraceptive Patch

11/10/2005

New Safety Information for Amevive (alefacept)

11/10/2005

NeoRx Announces Orphan Drug Designation for Picoplatin for Treatment of Small Cell Lung Cancer

11/09/2005

UCB Receives FDA Orphan Drug Designation for Brivaracetam for the Treatment of Symptomatic Myoclonus

11/08/2005

FDA Approves IND for SPC2996 in Chronic Lymphocytic Leukaemia

11/07/2005

Insulin Initiation With NovoMix 30 (Biphasic Insulin Aspart) Yields Significantly Greater Blood Glucose Reductions than Basal Insulin

11/07/2005

Xolair (omalizumab) - First in Class Treatment Launched in UK for Severe, Uncontrolled Asthma

11/04/2005

Pfizer's Revatio (Sildenafil Citrate) Receives European Approval to Treat Pulmonary Arterial Hypertension

11/03/2005

New Preservative-Free Glaucoma Treatment Cosopt (dorzolamide hydrochloride/timolol maleate) Now Available in Canada

11/03/2005

Exjade, a Breakthrough Once-Daily Oral Iron Chelator, Receives First Approval Worldwide in the U.S.

11/03/2005

FDA Approves Tarceva in Combination with Gemcitabine Chemotherapy for Treatment of Locally Advanced, Inoperable or Metastatic Pancreatic Cancer

11/01/2005

ACTOplus met (pioglitazone HCl and metformin HCl) Now Available in U.S. Pharmacies

10/31/2005

Pfizer's Zeldox Receives Approval in Europe to Treat Manic or Mixed Episodes Associated With Bipolar Disorder

10/31/2005

New Targeted Biological Treatment Available for Canadian Psoriasis Patients

10/31/2005

Abbott Receives FDA Approval for New Kaletra (Lopinavir/Ritonavir) Tablet Formulation for HIV Patients

10/28/2005

Galderma Receives FDA Approval for Clobex (Clobetasol Propionate) Spray for Moderate-to-Severe Plaque Psoriasis

10/28/2005

GlaxoSmithKline Announces Approval of Arranon (nelarabine) Injection

10/28/2005

European Commission Approves Kepivance (Palifermin) for Oral Mucositis in Cancer Patients Undergoing Blood and Bone Marrow Transplant

10/27/2005

Treatment Option Approved by FDA Now Available to Treat Anxiety Disorders

10/27/2005

Noxafil (Posaconazole) Oral Suspension Approved in European Union for Treatment of Invasive Fungal Infections

10/27/2005

Xolair Granted Marketing Authorization in Europe as Treatment for Severe Allergic Asthma

10/26/2005

EU Commission Approves Aptivus (Tipranavir) for Treatment of HIV

10/25/2005

FDA Grants Priority Review for Rituxan (Rituximab) Supplemental Biologics License Application for Front-Line Treatment of Intermediate-Grade or Aggressive Non-Hodgkin's Lymphoma

10/21/2005

Cephalon Receives Approvable Letter for Sparlon for Treatment of ADHD in Children and Adolescents

10/21/2005

Bayer Wins Approval for Avelox (Moxifloxacin) in Japan

10/20/2005

FDA Approves Levemir (Insulin Detemir [rDNA Origin] Injection) for Treatment of Diabetes in Children

10/18/2005

GlaxoSmithKline's Havrix (hepatitis A vaccine, inactivated) Now Approved For Use in Children Aged 12 Months and Older

10/18/2005

ALK-Abelló Announces Positive Results from New Grass Tablet Study

10/17/2005

FDA Approves Baxter's Flexbumin, the First and Only Albumin Solution to Be Packaged in a Flexible Container

10/17/2005

Ebixa, Extended Approval for Treatment of Moderate Alzheimer's Disease

10/13/2005

Exubera (Insulin Human) Receives Positive Opinion from CHMP for Treatment of Type 1 and Type 2 Diabetes

10/11/2005

Novo Nordisk Receives EU Approval of NovoMix 50 and NovoMix 70 Premixed Insulin Analogues

10/10/2005

FDA Approves Room Temperature Storage of ZLB Behring's Helixate FS

10/06/2005

Bayer Receives FDA Approval for Room Temperature Storage of Kogenate FS (Antihemophilic Factor (Recombinant)

10/06/2005

Remicade (Infliximab) Receives Approval in European Union for Treatment of Moderate to Severe Plaque Psoriasis

10/05/2005

FDA Approves Pfizer's Aromasin (Exemestane Tablets) for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women

10/05/2005

Follistim AQ Vial Now Available in 75 IU and 150 IU Presentations

10/05/2005

Shorter Course of Peg-Intron and Rebetol Combination Therapy Approved in European Union for Certain Hepatitis C Patients With Genotype 1 and Low Viral Load

10/05/2005

Schering AG Receives EU Approval for Novel Contrast Agent Vasovist

10/04/2005

Humira (Adalimumab) Receives FDA Approval for Treatment of Psoriatic Arthritis Patients on Humira Showed Substantial Improvement in Skin and Joint Symptoms of the Disease

10/04/2005

Xechem's Orphan Drug Status Approved for Its Sickle Cell Medicine in the European Union

10/04/2005

Humira (adalimumab) Receives FDA Approval for First-Line Treatment of Moderate to Severe Rheumatoid Arthritis

10/04/2005

Data and Safety Monitoring Board Recommends Discontinuation of Canvaxin Phase 3 Clinical Trial for Patients with Stage III Melanoma

10/03/2005

Sanofi Pasteur Notifies Health Care Providers of Need to Report Adverse Events Following Administration of Menactra(R) Meningococcal Vaccine

09/30/2005

FDA Issues Public Health Advisory on Strattera (Atomoxetine) for Attention Deficit Disorder

09/30/2005

FDA Advisory Committee Votes Unanimously to Recommend Approval of Exjade(R) for Once-Daily Oral Treatment of Chronic Iron Overload Due to Blood Transfusions

09/29/2005

FDA Approves Angeliq (Drospirenone/Estradiol) to Treat Menopausal Symptoms

09/29/2005

Critical Therapeutics Announces FDA Approval of Zyflo (Zileuton Tablets) for the Prevention and Chronic Treatment of Asthma

09/28/2005

Allergan Receives Positive Opinions for Combigan(TM) from 21 Countries in European Union

09/28/2005

Insmed Receives Approvable Letter for iPlex (rhIGF-I/rhIGFBP-3)

09/27/2005

EMEA Grants Orphan Drug Designation to Troxatyl (Troxacitabine) for Treatment of Acute Myeloid Leukemia

09/27/2005

FDA Approves Pfizer's Lipitor (atorvastatin calcium) to Reduce Risk of Strokes and Heart Attacks in Patients With Diabetes

09/26/2005

Baxter Announces the U.S. Launch of GammaGard Liquid 10% for Patients With Primary Immunodeficiency Disorders

09/26/2005

FDA Accepts Altace Supplemental New Drug Application for Delaying the Progression of Chronic Kidney Disease in Hypertensive, Non-Diabetic Patients

09/23/2005

European Commission Approves Use of Anti-Epileptic Keppra as Adjunctive Therapy in Children Four Years of Age and Older with Partial-Onset Seizures

09/23/2005

Cipralex Approved for the Treatment of Generalised Anxiety Disorder in the EU

09/21/2005

PrDiovan (valsartan) Approved to Reduce Cardiovascular Death in Those at High Risk

09/21/2005

Tarceva Approved in Europe for Lung Cancer

09/20/2005

Arimidex (Anastrozole) Gains Full FDA Approval for Adjuvant Treatment of Hormone Receptor-Positive Early Breast Cancer in Postmenopausal Women

09/19/2005

Once-Monthly Oral Bonviva Approved for Postmenopausal Osteoporosis in Europe

09/16/2005

FDA Approves Remicade (infliximab) as First and Only Biologic to Treat Ulcerative Colitis

09/16/2005

BioMarin Announces Positive Opinion for Naglazyme (Galsulfase) From European Regulatory Authority

09/16/2005

FDA Approves NovoLog (Insulin Aspart [rDNA Origin] Injection) for Treatment of Diabetes in Children

09/16/2005

FDA Expands Neulasta (Pegfilgrastim) Label, Extends First-Cycle Protection From Infection to Cancer Patients Receiving Moderately Myelosuppressive Chemotherapy

09/16/2005

Macugen (Pegaptanib Sodium Injection) Receives Positive Opinion From Europe's CHMP for Treatment of Wet Age-Related Macular Degeneration

09/15/2005

FDA Advisory Committee Recommends Accelerated Approval of GlaxoSmithKline's Arranon (nelarabine) Injection

09/15/2005

New Treatment Option for Second Leading Cause of Cancer Deaths in Canada, Health Canada Approves Erbitux (Cetuximab) for the Treatment of Metastatic Colorectal Cancer

09/15/2005

Alkermes Announces Risperdal Consta Approved in Italy

09/14/2005

FDA Oncologic Drugs Advisory Committee Recommends Revlimid for Full Approval

09/14/2005

Cephalon Receives FDA Approval to Market Sugar-Free Formulation of Actiq

09/14/2005

Pfizer Receives European Approval to Market Aromasin(R) for Adjuvant Treatment of Early Breast Cancer in Postmenopausal Women

09/13/2005

FDA Approves ParaGard IUD for Women Who Have Not Yet Had Children

09/12/2005

Health Canada Approves Groundbreaking Cancer Treatment Avastin (Bevacizumab, rhuMAb-VEGF) for Colorectal Cancer

09/09/2005

FDA Advisory Committee Recommends Approval of Exubera (insulin [rDNA origin] powder for oral inhalation) for Use in Adults With Type 1 and 2 Diabetes

09/09/2005

Biovail's Tramadol ER Receives FDA Approval

09/09/2005

Once-Monthly Oral Bonviva Approved for Postmenopausal Osteoporosis in Switzerland

09/06/2005

Labopharm Receives Regulatory Approval of Once-Daily Pain Product, Tramadol, for 22 European Countries

09/06/2005

Ambien CR (Zolpidem Tartrate Extended-Release Tablets) CIV Receives FDA Approval for the Treatment of Insomnia

08/31/2005

Health Canada Approves New Targeted Radioimmunotherapy

08/31/2005

GlaxoSmithKline Announces FDA Approval of Fluarix(TM) (Influenza Virus Vaccine)

08/31/2005

FDA Grants Expanded Label for Ventavis (Iloprost) Inhalation Solution

08/31/2005

Cephalon Receives Approval to Market Modafinil for Shift Work Sleep Disorder in Germany

08/31/2005

FDA Approves Tercica's Increlex for Short Stature Caused by Severe Primary IGF-1 Deficiency

08/30/2005

ACTOplus Met Approved by the FDA for Type 2 Diabetes

08/25/2005

FDA Clears Masimo SET LNOP Blue(TM) Sensor, the First and Only Pulse Oximeter Sensor to Accurately Monitor Cyanotic Babies

08/25/2005

KV Pharmaceutical Announces First Asian Approval for Gynazole-1

08/24/2005

FDA Approves Aceon to Reduce Risk of Cardiovascular Mortality or Non-Fatal MI in Patients With Stable Coronary Artery Disease

08/19/2005

New Formulation of Allergan's Alphagan P Receives U.S. FDA Approval

08/19/2005

Oral Solution Formulation of Namenda (Memantine HCl), the Only FDA-Approved Oral Solution for Moderate to Severe Alzheimer's Disease, Now Available

08/18/2005

First Single-Dose Oral Antibiotic Zmax (Azithromycin Extended Release) Available in US Pharmacies for Adults with Certain Types of Sinusitis and Pneumonia

08/18/2005

Ariad Receives Orphan Drug Designations for AP23573 in the Treatment of Both Soft-Tissue and Bone Sarcomas

08/18/2005

Schering's New Low-Dose Oral Contraceptive Yasminelle (Ethinyl Estradiol/Drospirenone) Approved in the Netherlands

08/15/2005

FDA Approves Actonel With Calcium (Risedronate Sodium With Calcium Carbonate Tablets) for Postmenopausal Osteoporosis

08/15/2005

Humira (Adalimumab) Approved in Europe for Treatment of Psoriatic Arthritis and as First-Line Treatment of Severe Rheumatoid Arthritis

08/15/2005

FDA Approves Fortical (calcitonin-salmon), Unigene's Nasal Calcitonin Product for Postmenopausal Osteoporosis

08/12/2005

FDA Approves Isotretinoin Pregnancy Risk Management Program

08/12/2005

Concerta (Methylphenidate HCl) Approved for Treatment of ADHD in Adolescents

08/08/2005

FDA Approves Levaquin (Levofloxacin) for Short-Course Treatment of Acute Bacterial Sinusitis

08/04/2005

FDA Approves Diovan (Valsartan) to Reduce Cardiovascular Death in Heart Attack Survivors at High Risk

08/01/2005

FDA Grants Fast Track Designation for Panitumumab for Treatment of Metastatic Colorectal Cancer

08/01/2005

FDA Approves New Use for Celebrex (Celecoxib), for Patients with Ankylosing Spondylitis

08/01/2005

FDA Grants Orphan Drug Designation for Lysosomal Acid Lipase

07/27/2005

FDA Approves S-Caine Patch (Lidocaine/Tetracaine) Topical Local Anesthetic Patch

07/25/2005

FDA Approves Rozerem (Ramelteon), Non-Scheduled Prescription Sleep Medication

07/22/2005

FDA Approves Onyx Liquid Embolic System for Treatment of Brain Vascular Disorder

07/22/2005

FDA Expands Indication for Adderall XR (Mixed Salts of a Single-Entity Amphetamine Product) Confirming Safety and Efficacy in Adolescents

07/22/2005

FDA Issues Approvable Letter for Entereg (Alvimopan), for Management of Postoperative Ileus

07/19/2005

FDA Grants Fast Track Status for the Investigational HIV Protease Inhibitor 640385 (VX-385)

07/18/2005

Avelox IV (Moxifloxacin) Approved in Europe to Treat Complicated Skin and Skin Structure Infections

07/18/2005

Health Canada Approves Influvac, Influenza Vaccine Will Be Available for Flu Season

07/15/2005

FDA Approves Re-Formulated Clarinex (desloratadine) Reditabs(R) Tablets - Orally Disintegrating Prescription Antihistamine

07/14/2005

Bioniche Launches Sotradecol Injection (Sodium Tetradecyl Sulfate Injection) for Varicose Veins in U.S.

07/14/2005

Tarceva (Erlotinib) Granted Approval in Canada for the Treatment of Advanced Non-Small Cell Lung Cancer

07/13/2005

European Commission Approves New Use of Arixtra for Prevention of Venous Thromboembolic Events in Abdominal Surgery

07/08/2005

Aczone (dapsone) Gel 5% Approved for Treatment of Acne by the FDA

07/07/2005

European Medicines Agency Grants Orphan Drug Designation for PTC124 for Treatment of Duchenne Muscular Dystrophy and Cystic Fibrosis

07/07/2005

FDA Approves of Metrogel (Metronidazole) Topical Gel 1% for Rosacea

07/06/2005

FDA Approves Megace ES for Anorexia, Cachexia, or Unexplained, Significant Weight Loss in Patients With AIDS

06/30/2005

FDA Approves New Indication for Topamax (Topiramate) as Initial Monotherapy for Adults and Children with Epilepsy

06/30/2005

FDA Approves of Avelox (Moxifloxacin HCl) for Treatment of Complicated Skin and Skin Structure Infections

06/28/2005

Xenical Gains European Approval for Use in Young People

06/24/2005

FDA Approves UCB's Keppra (Levetiracetam) for Use in Childhood Epilepsy

06/24/2005

FDA Approves Bidil for Treatment of Heart Failure in Black Patients

06/23/2005

U.S. FDA Approves New Anti-HIV Drug Aptivus For Use In Combination Therapy

06/17/2005

AstraZeneca Announces US Label Change for Iressa (Gefitinib) and New Distribution

06/16/2005

FDA Approves First-Ever Treatment for Adults, Teens with Diarrhea Caused by Cryptosporidium Infection

06/16/2005

FDA Approves Tygacil (Tigecycline), First-In-Class Antibiotic

06/15/2005

FDA Approves Oral Xeloda (Capecitabine) for Adjuvant Treatment of Colon Cancer

06/13/2005

Pfizer's Single-Dose Antibiotic Zmax (Azithromycin Extended Release) Receives FDA Approval

06/13/2005

Novartis Receives EU Marketing Authorization for Diovan to Treat People With Heart Failure

06/13/2005

FDA Approves Pfizer's Lyrica (Pregabalin) as Epilepsy Add-On Treatment for Partial Onset Seizures

06/10/2005

Temodal (Temozolomide) Approved in European Union For Treatment of Newly Diagnosed Glioblastoma Multiforme

06/09/2005

Byetta (Exenatide), Newly Approved First-in-Class Treatment for Type 2 Diabetes, Now Available in US

06/08/2005

Actelion Launches Tracleer (Bosentan) in Pulmonary Arterial Hypertension in Japan

06/08/2005

Antigenics' Oncophage Cancer Vaccine Receives European Orphan Drug Designation for Renal Cell Carcinoma

06/08/2005

Virulizin(R) Granted Orphan Drug Status in European Union

06/07/2005

Virulizin, Treatment For Pancreatic Cancer, Granted Orphan Drug Status in European Union

06/07/2005

Oncophage (HSPPC-96) Cancer Vaccine Receives European Orphan Drug Designation for Renal Cell Carcinoma

06/07/2005

Convenient New Formulation of Aricept (Donepezil) Now Available for Treatment of Mild-To-Moderate Alzheimer's Disease

06/06/2005

FDA Approves Revatio (Sildenafil Citrate) As Treatment for Pulmonary Arterial Hypertension

06/03/2005

FDA Approves Extended-Release Glumetza (metformin hydrochloride) for Type II Diabetes

06/01/2005

Europe Grants Orphan Drug Designation to Proxinium for Treatment of Head and Neck Cancer

06/01/2005

Xolair (Omalizumab), Antibody Therapy for Asthma, Available in Canada

06/01/2005

FDA Expands Enbrel (Etanercept) Psoriatic Arthritis Indication

06/01/2005

Health Canada Approves Glumetza (Metformin) to Treat Type II Diabetes

06/01/2005

FDA Grants Orphan Drug Status to Naglazyme (galsulfase), Treatment for Mucopolysaccharidosis VI

05/31/2005

Taxotere (Docetaxel) Approved by Health Canada to Treat Prostate Cancer

05/27/2005

Cellegesic (Nitroglycerin Ointment) Launched in the United Kingdom

05/27/2005

FDA Approves Zemplar (Paricalcitol) Capsules For Earlier Treatment Of Kidney Disease Complication

05/27/2005

Europe Approves Invirase (Saquinavir Mesylate) 500 mg Tablet for the Treatment of HIV

05/27/2005

European Agency Issues Positive Opinion for Use of Arixtra (Fondaparinux) in Prevention of Venous Thromboembolic Events in Abdominal Surgery

05/27/2005

FDA Grants Approval for Focalin XR (Dexmethylphenidate) for Treatment of Attention-Deficit Hyperactivity Disorder in Adults, Adolescents and Children

05/25/2005

FDA Issues Approvable Letter for Retaane Suspension (Anecortave) for treatment of Wet Age-Related Macular Degeneration

05/24/2005

FDA Approves Updated Labeling for Coreg (Carvedilol) Showing Benefits for Heart Attack Patients With Damaged Hearts and Heart Failure Patients

05/24/2005

Brazil Approves Macugen (Pegaptanib Sodium Injection) in Brazil for the Treatment of Neovascular (Wet) Age-Related Macular Degeneration

05/20/2005

Depomed Receives FDA Approval of Proquin XR for Uncomplicated Urinary Tract Infections

05/19/2005

FDA Approves Atacand (Candesartan Cilexetil) For Use With An Ace Inhibitor In The Treatment Of Heart Failure

05/18/2005

Certican (Everolimus) Approved by Swissmedic to Reduce Risk of Organ Rejection in Heart and Kidney Transplant Patients

05/17/2005

Trizivir (Abacavir Sulfate, Lamivudine, and Zidovudine) Receives Traditional Approval Status From FDA

05/17/2005

FDA Approves Remicade (Infliximab) for Psoriatic Arthritis

05/16/2005

FDA Approves Pegasys (Peginterferon alfa-2a) as Pegylated Interferon for the Treatment of Chronic Hepatitis B

05/14/2005

FDA Grants Access to Sorafenib (BAY 43-9006) for Individuals With Advanced Renal Cell Carcinoma

05/13/2005

Anti-Fungal Agent Mycamine (Micafungin Sodium) Available to Physicians in US

05/12/2005

FDA Grants Orphan Drug Designation for Troxatyl (Troxacitabine)

05/12/2005

FDA Grants Orphan Drug Status to PulmoLAR, Treatment for Pulmonary Arterial Hypertension

05/10/2005

Diovan Receives European Union Approval for Treatment of Heart Attack Survivors

05/09/2005

FDA Approves Triglide, A Novel Formulation Of Fenofibrate, for Treatment of Lipid Disorders

05/06/2005

FDA Issues Approval Letter For Tramadol ODT, for Moderate to Severe Pain

05/06/2005

Health Canada Approves Macugen (Pegaptanib Sodium Injection) Treatment of Neovascular (Wet) Age Related Macular Degeneration

05/05/2005

FDA Approves Requip (Ropinirole HCl) for Treatment of Moderate-to-Severe Primary Restless Legs Syndrome in Adults

05/03/2005

FDA Approves Boostrix® Vaccine for Adolescents Against Pertussis

05/02/2005

FDA Approves Baxter's Gammagard Liquid 10% for Patients With Primary Immunodeficiency Disorders

05/02/2005

FDA Approves Once-Daily Kaletra-Based (Lopinavir/Ritonavir) Treatment Regimen

04/29/2005

FDA Approves of Byetta (Exenatide) Injection, Treatment for Type 2 Diabetes

04/25/2005

5-Day Antibiotic Treatment For Acute Sinusitis: Presented at Health Canada Approves New Indication for Ketek (Telithromycin)

04/25/2005

Multiferon (Natural Human Alpha Interferon) Approved for Sale in the Philippines

04/21/2005

Europe Grants Marketing Authorization for Aclasta (Zoledronic Acid for Infusion), Treatment for Paget's Disease

04/20/2005

Health Canada Allows "Morning After Pill", Plan B (Levonorgestrel) To Be Available Without Prescription

04/19/2005

Equetro (Carbamazepine Extended-Release) Now Available in US for Treatment of Manic and Mixed Episodes in Bipolar Disorder

04/19/2005

FDA Public Health Advisory About Elidel (Pimecrolimus) Cream and Protopic (Tacrolimus) Ointment

04/14/2005

FDA Approves Hyzaar (Losartan Potassium-Hydrochlorothiazide) Fixed-Dose Combination

04/14/2005

FDA Grants Orphan Drug Status for Panzem (2ME2), Treatment for Ovarian Cancer

04/13/2005

FDA Issues Public Health Advisory for Antipsychotic Drugs used for Treatment of Behavioral Disorders in Elderly Patients

04/11/2005

FDA Approves Orphan Drug Retisert (Fluocinolone Acetonide Intravitreal Implant), for Treatment of Chronic Non-Infectious Uveitis

04/11/2005

FDA Approves Liquid Formulation of WinRho SDF for Treatment of Immune Thrombocytopenic Purpura

04/11/2005

FDA Issues Approvable Letter for Ambien CR (Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia

04/11/2005

Health Canada Approves Femara (Letrozole), Treatment Option to Improve Disease-Free Survival Beyond Five Years of Breast Cancer Diagnosis

04/08/2005

FDA Approves Fosamax Plus D (Alendronate Sodium/Cholecalciferol With Vitamin D) to Reduce Risk of Hip and Spine Fractures

04/07/2005

New FDA Labeling for Pfizer's Celebrex, Pfizer Agrees to Suspend Sales of Bextra

04/07/2005

Lunesta Now Widely Available by Prescription to Treat Insomnia Estimated 100 Million Americans Suffer from Insomnia

04/04/2005

Novo Nordisk Receives EU Approval for Broader Use of Levemir and NovoRapid

04/04/2005

Helsinn's New Antiemetic Drug Aloxi Receives Marketing Authorization in Europe

04/01/2005

FDA Approves Intravenous Formulation for Nexium (Esomeprazole Magnesium) for GERD

04/01/2005

Xeloda (Capecitabine) Granted European Union Approval for Adjuvant Therapy in the Treatment of Colon Cancer

03/31/2005

FDA Approves Asmanex (mometasone furoate) for Once Daily Management of Asthma

03/30/2005

Health Canada Approves New Indication for Fragmin (Dalteparin Sodium), for Reduction of Cancer-Associated Thrombosis

03/30/2005

FDA Approves Baraclude (Entecavir) for Treatment of Chronic Hepatitis B

03/29/2005

FDA Approves Zofran (Ondansetron) For Use in Children as Young as One Month of Age

03/29/2005

FDA Approves Depo-subQ Provera 104 (Medroxyprogesterone) for Management of Endometriosis Pain

03/28/2005

FDA Approves Once-Monthly Boniva (Ibandronate Sodium) for Osteoporosis

03/28/2005

FDA Grants Full Approval for Velcade (Bortezomib) for Injection; Claims Include Survival Advantage and Use in Second-Line Multiple Myeloma

03/28/2005

ISTA Pharmaceuticals Receives FDA Approval for Xibrom for the Treatment of Ocular Inflammation Following Cataract Surgery

03/25/2005

FDA Issues Approvable Letter for Sugar-Free Formulation of Actiq (Oral Transmucosal Fentanyl Citrate)

03/23/2005

Colombian Food and Drug Agency Approves Impavido (Miltefosine) for Parasitic Skin Disease

03/22/2005

Treatment for Locally Advanced or Metastatic Lung Cancer, Tarceva (Erlotinib), Granted First European Approval in Switzerland

03/22/2005

Ventavis (Iloprost) Now Commercially Available for the Treatment of Pulmonary Arterial Hypertension

03/21/2005

FDA Approves New Drug, Symlin (Pramlintide Acetate), to Treat Type 1 and Type 2 Diabetes

03/18/2005

FDA Advisory Panel Recommends Licensure of Adacel Vaccine for Combined Protection against Tetanus, Diphtheria and Pertussis

03/18/2005

European Commission Grants Marketing Authorization for anti-epileptic Zonegran (Zonisamide)

03/17/2005

FDA Approves Antifungal Mycamine (Micafungin Sodium)

03/17/2005

Taxol (Paclitaxel) Approved in Europe for the Adjuvant Treatment of Node-Positive Breast Cancer

03/17/2005

Abilify (Aripiprazole) Granted Approval for New Indication, Bipolar I Disorder

03/16/2005

FDA Approves Temodar (Temozolomide) as Treatment for Patients With Newly Diagnosed Glioblastoma Multiforme

03/14/2005

FDA Approves Xopenex HFA (Levalbuterol Tartrate) Metered-Dose Inhaler

03/14/2005

Avastin (Bevacizumab, rhuMAb-VEGF), Treatment for Advanced Colorectal Cancer, Launching in Europe

03/14/2005

Public Advisory - Health Canada Endorsed Important Safety Information on Crestor (Rosuvastatin)

03/08/2005

Canada Expands Approval of Cancidas (Caspfungin Acetate) for Empirical Treatment of Fungal Infections in Febrile-Neutropenic Patients

03/08/2005

France Approves Use of Remodulin (Treprostinil Sodium) for Primary Pulmonary Hypertension

03/07/2005

Femara Approved in Germany as the Only Hormonal Therapy Given After Standard Tamoxifen for Post-menopausal Woman with Early Breast Cancer

03/07/2005

Abilify (Aripiprazole) Granted Approval for New Indication, Bipolar I Disorder

03/04/2005

FDA Approves Clarinex-D 24 Hour Prescription-Strength Once-Daily Nondrowsy Antihistamine with a Decongestant

03/03/2005

Europe Approves Thyrogen (Thyrotropin Alfa) for Use in Thyroid Cancer Ablation

02/28/2005

Canasa (Mesalamine) Suppository for Treatment of Ulcerative Proctitis Launched in US

02/28/2005

FDA Approves First Ever Treatment for Hepatitis C in Patients with HIV

02/23/2005

FDA Approves Atacand (Candesartan Cilexetil) for the Treatment of Heart Failure

02/22/2005

FDA Grants Fast Track Designation for Aerosolized Amikacin

02/18/2005

EU Scientific Committee Recommends Approval of Cymbalta (Duloxetine) For Treatment of Diabetic Peripheral Neuropathic Pain

02/18/2005

Orphan Drug Status Granted for Once-Daily Tramadol for Treatment of HIV-Associated Neuropathy

02/18/2005

FDA Grants Priority Review to Keppra (Levetiracetam) for Use in Childhood Epilepsy

02/14/2005

New Opiate Addiction Treatment, Subutex (Buprenorphine Hydrochloride), Approved by Health Canada

02/10/2005

Health Canada Approves Pediatric Indication for Prevacid (Lansoprazole) for Children with Gastroesophageal Reflux Disease

02/10/2005

Health Canada Requests Suspension of Sales of Adderall XR

02/08/2005

Health Canada Endorses Important Safety Information on Ezetrol (Ezetimibe)

02/07/2005

FDA Grants Full Approval to Doxil (Doxorubicin), Treatment for Progression or Recurrence of Ovarian Cancer

02/07/2005

Ozone Friendly Formulation, Flovent HFA (Fluticasone Propionate HFA) Inhalation Aerosol, Now Available in US

02/04/2005

FDA Approves New Eloxatin (Oxaliplatin) Formulation

02/04/2005

FDA Grants Orphan Drug Designation for Proxinium, Treatment for Advanced, Recurrent Head and Neck Cancer

01/31/2005

New Treatment Guidelines Recommend Valcyte (Valganciclovir) for AIDS-Related Cytomegalovirus Retinitis

01/26/2005

Norditropin NordiFlex (somatropin [rDNA] injection), Treatment for Growth Hormone Deficiency, Now Available in US

01/25/2005

Japan Approves Enbrel (Etanercept) for Treatment of Rheumatoid Arthritis

01/25/2005

Abraxane (Paclitaxel) for Injectable Suspension, Treatment for Metastatic Breast Cancer, Available in US in Early February

01/21/2005

Eyetech Announces Launch Date for Macugen (Pegaptanib Sodium Injection)

01/19/2005

Immunomedics Announces Canadian Approval of LeukoScan

01/19/2005

Vesicare (Solifenacin Succinate) Now Available in the United States

01/17/2005

Warner Chilcott Announces Approval of Low-Dose femhrt® 0.5 mg/2.5 mcg

01/14/2005

European Commission Approves Avastin (Bevacizumab, rhuMAb-VEGF), Treatment for Metastatic Colorectal Cancer

01/12/2005

Oral Contraceptive Yasmin (Drospirenone/Ethinyl Estradiol) Approved in Canada

01/12/2005

Scent-Free Formulation of Nasonex (Mometasone Furoate Monohydrate) Launched in US

01/11/2005

First New Treatment for Alcoholism in Ten Years, Now Available Campral (Acamprosate Calcium) Delayed-Release Tablets

01/10/2005

FDA Approves Abraxane (paclitaxel) for Treatment of Metastatic Breast Cancer

01/07/2005

FDA Issues Approvable Letter for Bonefos (Clodronate) for Adjuvant Treatment of Breast Cancer

01/06/2005

Strattera (Atomoxetine), Non-Stimulant Medication For Attention-Deficit/Hyperactivity Disorder, Now Approved In Canada

01/06/2005

Health Canada Approves New Cream Treatment, Aldara (Imiquimod) for Basal Cell Carcinoma

01/06/2005

Vitrase (Hyaluronidase Injection) Now Available to US Ophthalmologists

01/05/2005

FDA Grants "Fast Track" Status for ACAM2000 Smallpox Vaccine

01/03/2005

FDA Approves Expanded Indication for Bexxar (Tositumomab) in Non-Hodgkin's Lymphoma

01/03/2005

FDA Approves Lyrica (Pregabalin) for Treatment of Neuropathic Pain

12/29/2004

FDA Approves Ventavis (Iloprost) for Treatment of Pulmonary Arterial Hypertension

12/29/2004

FDA Approves Antifungal VFEND (Voriconazole) for Treatment of Serious Bloodstream Infections Caused by Candida in Nonneutropenic Patients

12/29/2004

FDA Approves Prialt (Ziconotide Intrathecal Infusion) for Severe Chronic Pain

12/23/2004

FDA Approves Enablex (Darifenacin) for Treatment of Overactive Bladder

12/21/2004

FDA Approves Enjuvia (Synthetic Conjugated Estrogens, B) 0.3 and 0.45 Mg Tablets

12/21/2004

FDA Approves Remicade (Infliximab) for Patients with Ankylosing Spondylitis, Label Also Updated

12/20/2004

FDA Approves New 500 mg Tablet Formulation of Invirase (Saquinavir Mesylate)

12/20/2004

FDA Approves Macugen (Pegaptanib Sodium) for Treatment of Neovascular (Wet) Age-Related Macular Degeneration

12/16/2004

FDA Grants Remicade (Infliximab) Fast Track Designation For Treatment Of Active Ulcerative Colitis

12/16/2004

FDA Approves Kepivance (Palifermin) for Severe Oral Mucositis in Cancer Patients Undergoing Bone Marrow Transplant

12/16/2004

FDA Approves Nasonex (Mometasone ) for Treatment of Nasal Polyps

12/16/2004

FDA Approves Lunesta (Eszopiclone), Formerly Estorra, for Treatment of Insomnia

12/15/2004

FDA Approves Bausch & Lomb's Zylet Ophthalmic Combination Rx Drug

12/15/2004

FDA Approves Eligard (Leuprolide Acetate) 6-Month Formulation For Prostate Cancer

12/13/2004

FDA Approves Equetro (Extended-Release Carbamazepine) for Bipolar Disorder

12/08/2004

FDA Grants Orphan Drug Designation for PTC124 for Treatment of Cystic Fibrosis

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