| 参考译名 |
英文名称 |
美国上市时间
生产厂家 |
参考适应症 |
规格 |
价格 |
| 2007年期间 |
| |
Vidaza
azacitidine |
2007/01/26
Pharmion |
indicated for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia |
|
美元
  |
| |
Sutent
sunitinib |
2007/02/02
CP Pharmaceuticals |
for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate; for the treatment of advanced renal cell carcinoma. |
|
2116美元
|
| |
Aranesp
paclitaxel |
2007/02/15
Abraxis |
for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. |
|
美元
|
| |
Aranesp
darbepoetin alfa
(同时,见2007 年4月10日) |
2007/03/09
Amgen |
for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis, and for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. |
|
美元
|
| |
Epogen/Procrit
epoetin alfa |
2007/03/09
Amgen |
is indicated for the treatment of anemia related to therapy with zidovudine in HIV-infected patients. EPOGEN™ is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEN™ is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis, or gastrointestinal bleeding, which should be managed appropriately. |
|
美元
|
| |
Tykerb
lapatinib ditosylate
(同时,见2007年4月27日) |
2007/03/13
SmithKline Beecham |
for use in combination with capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 (ErbB2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab.
|
|
美元
|
| |
Soliris
eculizumab |
2007/03/16
Alexion |
for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. |
|
美元
|
| |
Aranesp
darbepoetin alfa
(同时,见2007年03月09日) |
2007/04/10
Amgen |
|
|
美元
|
| |
Tykerb
lapatinib ditosylate
(同时,见2007年03月13日) |
2007/04/27
SmithKline Beecham |
|
|
美元
|
| |
Fragmin
dalteparin sodium |
2007/05/01
Pharmacia & Upjohn |
provides for the use of Fragmin (dalteparin sodium injection) for extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in patients with cancer. |
|
美元
|
| 2006年期间 |
舒尼替尼
苹果酸舒尼替尼 |
Sutent
sunitinib |
2006/01/26
辉瑞公司
Pfizer |
转移性肾细胞癌
胃肠道间质肿瘤
转移性乳癌
神经内分泌癌
晚期肺癌
转移性肾细胞癌
胃肠道间质肿瘤
转移性乳癌
神经内分泌癌
晚期肺癌 |
12.5毫克/胶囊
28胶囊/瓶 |
2116美元
|
25毫克/胶囊
28胶囊/瓶 |
4,783美元
|
50毫克/胶囊
28胶囊/瓶 |
9,567美元
|
| |
Rituxan
Rituximab |
Feb 10 2006
Genentech, Inc |
non-Hodgkin's lymphoma |
|
美元
|
| |
Erbitux
cetuximab |
Mar 01 2006
Imclone |
For use in combination with radiation therapy (RT) for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) or as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed. |
|
美元
|
| |
Dacogen
decitabine |
May 05 2006
MGI PHARMA INC |
for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. |
|
美元
|
| |
Thalomid
thalidomide |
May 26 2006
Celgene |
Multiple myeloma |
|
美元
|
| |
|
|
|
|
|
| |
|
|
|
|
|
和美新
托泊替康 |
HYCAMTIN
TOPOTECAN HCL |
2006-06-14
葛兰素史克
Glaxo SmithKline |
卵巢癌
小细胞肺癌
宫颈癌 |
4毫克/瓶 |
819美元
|
阿瓦斯丁
(阿瓦司丁) |
AVASTIN
BEVACIZUMAB
(同时，见2006年10月11日、2006年09月21日、2004年02月26日) |
2006/06/20
罗氏销售
Roche销售
Genentech 生产 |
乳腺癌
结肠癌 |
100毫克/4毫升/瓶 |
630美元
|
| 100毫克/4毫升/瓶，4瓶 |
3046美元
|
| 400毫克/16毫升/瓶 |
2179美元
|
| |
|
|
|
|
|
扑瑞赛
达沙替尼 |
SPRYCEL
DASATINIB |
2006/06/28
百时美施贵宝
Bristol Myers Squibb |
对伊马替尼(imatinib,Gleevec)等一线药物化疗不敏感的各期慢性粒细胞白血病(CML)
对其他疗法无效或不能耐受的Ph染色体阳性的急性淋巴细胞白血病(ALL) |
20毫克/片
60片/瓶 |
2853美元
|
50毫克/片
60片/瓶 |
5561美元
|
70毫克/片
60片/瓶 |
5561美元
|
|
Revlimid
lenalidomide |
Jun 29 2006
Celegene |
Multiple myeloma |
|
美元
|
| |
Gemzar
gemcitabine hcl |
Jul 14 2006
Lilly |
Ovarian cancer |
|
美元
|
| |
Oncaspar
pegaspargase |
Jul 24 2006
Enzon |
Acute lymphoblastic leukemia |
|
美元
|
| |
Neumega
oprelvekin |
Sep 13 2006
Wyeth |
warnings regarding ophthalmologic and ventricular arrhythmias adverse events have been added to the oprelvekin (Neumega) label |
|
美元
|
| |
epirubicin hcl
epirubicin hcl |
Sep 15 2006
Mayne |
as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. |
|
美元
|
阿瓦斯丁
（阿瓦司丁） |
AVASTIN
BEVACIZUMAB
（同时，见2006年10月11日、2006年06月20日、2004年02月26日） |
2006/09/21
罗氏销售
Roche销售
Genentech 生产 |
|
|
美元
|
| |
Fentora
fentanyl citrate |
Sep 25 2006
Cephalon |
for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.
|
|
美元
|
| |
Gleevec
imatinib mesylate
（同时，见May 10 2001、Feb 01 2002、Feb 01 2002、Dec 20 2002、Apr 18 2003、May 20 2003、Dec 08 2003、Sep 27 2006、Oct 19 2006） |
Sep 27 2006
Novartis |
for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). |
|
美元
|
| 帕尼单抗 |
VECTIBIX
PANITUMUMAB |
2006/09/27
安进公司
Amgen |
标准化疗失败的转移性结肠癌 |
100毫克/5毫升/瓶 |
1296美元
|
| 200毫克/10毫升/瓶 |
2285美元
|
| 400毫克/20毫升/瓶 |
4342美元
|
|
Rituxan
rituximab |
Sep 29 2006
Genentech |
for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. |
|
美元
|
| |
Rituxan
rituximab |
Sep 29 2006
Genentech |
for the first-line treatment of patients with low grade or follicular, CD20-positive B-cell non-Hodgkin’s lymphoma. |
|
美元
|
| |
Zolinza
vorinostat |
Oct 06 2006
Merck |
for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with progressive, persistent, or recurrent disease on or following two systemic therapies. |
|
美元
|
| |
Avastin
bevacizumab
（同时，见2006年09月21日、2006年06月20日、2004年02月26日） |
Oct 11 2006
Genentech |
a first-line treatment of patients with locally advanced, metastatic or recurrent non-small cell lung cancer in combination with platinum-based chemotherapy |
|
|
泰索帝
多西他赛 |
TAXOTERE
DOCETAXEL |
2006/10/17
赛诺菲-安万特
Sanofi Aventis |
联合顺铂和5－氟尿嘧啶治疗以前未接受化疗的晚期胃癌，包括胃食管交界癌
乳腺癌 |
20毫克/0.5毫升/瓶 |
332美元
|
| 80毫克/2毫升/瓶 |
1328美元
|
格列卫
甲磺酸伊马替尼 |
GLEEVEC
IMATINIB MESYLATE |
2006/10/19
诺华制药
Novartis |
|
100毫克/片，30胶襄/盒，非专利药GENERIC |
550美元
|
| 100毫克/片，60胶襄/盒，非专利药GENERIC |
935美元
|
| 100毫克/片，120胶襄/盒，非专利药GENERIC |
1926美元
|
| 400毫克/片，30胶襄/盒，非专利药GENERIC |
1552美元
|
| 400毫克/片，60胶襄/盒，非专利药GENERIC |
2639美元
|
| |
Herceptin
Trastuzumab
（同时，见Nov 16 2006、Sep 25 1998、Feb 09 2000、Aug 28 2002、Aug 28 2002） |
2006/11/16
Genentech |
Early Stage Breast Cancer After Primary Therapy |
|
美元
|
| |
Velcade
bortezombi |
2006/12/08
Millennium |
for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy |
|
美元
|
| |
Kineret
anakinra |
2006/12/15
Amgen |
pediatric Use section of the US product label and to fulfill PMC #3 to assess the safety and efficacy of anakinra in pediatric patients with juvenile rheumatoid arthritis |
|
美元
|
| |
PegIntron
Peginterferon alfa-2b |
2006/12/22
Schering |
trade name from PEG-Intron to PegIntron |
|
美元
|
| 2005年期间 |
|
Abraxane
paclitaxel protein-bound particles |
Jan 07 2005
AM Bioscience |
For the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracyline unless clinically contraindicated |
|
美元
|
| |
Doxil
doxorubicin liposomal |
Jan 28 2005
Alza |
Conversion to regular approval for treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy |
|
美元
|
| |
Temodar
temozolomide |
Mar 15 2005
Schering |
Conversion to regular approval for the treatment of patients with newly diagnosed high grade gliomas concomitantly with radiotherapy and then as adjuvant treatment |
|
美元
|
| |
Velcade
bortezomib |
Mar 25 2005
Millenium |
Conversion to regular approval for treatment of multiple myeloma patients who have received as least one prior therapy |
|
美元
|
| |
Xeloda
capecitabine |
Jun 15 2005
Roche |
Adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred |
|
美元
|
| |
Arimidex
anastrozole |
Sep 16 2005
AstraZeneca |
Conversion to regular approval for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer |
|
美元
|
| |
Aromasin
exemestane |
Oct 05 2005
Pharmacia |
For adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to AROMASIN™ for completion of a total of five consecutive years of adjuvant hormonal therapy
|
|
美元
|
| |
Arranon
nelarabine |
Oct 28 2005
GlaxoSmithKline |
Accel. Approv. (clinical benefit not established) for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens |
|
美元
|
| |
Tarceva
erlotinib |
Nov 02 2005
OSI |
For use in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer |
|
美元
|
| |
Nexavar
sorafenib |
Dec 20 2005
Bayer |
For the treatment of patients with advanced renal cell carcinoma |
|
美元
|
| |
Revlimid
lenalidomide |
Dec 27 2005
Celgene |
for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities |
|
美元
|
| 2004年期间 |
|
Eloxatin
oxaliplatin |
Jan 09 2004
Sanofi Synthelabo |
Conversion to regular approval for use in combination with infusional 5-Fluorouracil (5-FU) and Leucovorin (LV) for the treatment of patients previously untreated for advanced colorectal cancer |
|
美元
|
| |
Alimta
pemetrexed disodium |
Feb 04 2004
Lilly |
For use in the treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery |
|
美元
|
| |
Erbitux
cetuximab |
Feb 12 2004
Imclone |
Accel. Approv. (clinical benefit not established) for treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); as a single agent, treatment of EGFR-expressing metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy |
|
美元
|
| |
Avastin
bevacuzimab |
Feb 26 2004
Genentech |
First-line treatment of patients with metastatic carcinoma of the colon and rectum (in combination with intravenous 5-fluorouracil-based chemotherapy) |
|
美元
|
| |
Vidaza
azacitidine |
May 19 2004
Pharmion |
For use for the treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia |
|
美元
|
| |
Taxotere
docetaxel |
May 19 2004
Aventis Pharmaceutical |
For use in combination with prednisone as a treatment for patients with androgen independent (hormone refractory) metastatic prostate cancer
|
|
美元
|
| |
Gemzar
gemicitabine |
May 19 2004
Lilly |
For use in combination with paclitaxel for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated |
|
美元
|
| |
Taxotere
docetaxel |
Aug 18 2004
Aventis Pharmaceutical |
For use in combination with doxorubicin and cyclophosphamide for the adjuvant treatment of patients with operable nodepositive breast cancer |
|
美元
|
力比泰（利比泰）
培美曲塞二钠 |
Alimta
pemetrexed disodium |
2004/08/19
美国礼来公司
Eli Lilly |
联合顺铂一线治疗不可切除的恶性胸膜间皮瘤。单药二线治疗非小细胞肺癌。
Accel. Approv. (clinical benefit not established) as a single agent for the treatment of patients with locally advanced or metastatic non-small lung cancer after prior chemotherapy |
500毫克/瓶
非专利药GENERIC |
1681美元
|
|
Histrelin implant
histrelin acetate |
Oct 12 2004
Valera |
For the palliative treatment of advanced prostate cancer |
|
美元
|
| |
Femara
letrozole |
Oct 29 2004
Novartis |
Accel. Approv. (clinical benefit not established) for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received five years of adjuvant tamoxifen therapy. |
|
美元
|
| |
Eloxatin
oxaliplatin |
Nov 04 2004
Sanofi Synthelabo |
for use in combination with infusional 5-FU/LV, for the adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor |
|
美元
|
| |
Tarceva
erlotinib |
Nov 18 2004
OSI |
For treatment of locally advanced or metastatic Non Small-Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen |
|
美元
|
| |
Kepivance
palifermin |
Dec 15 2004
Amgen |
Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoetic stem cell support |
|
美元
|
| |
Bexxar
Tositumomab/I-131 tositumomab |
Dec 22 2004
GlaxoSmithKline |
Expand the indication to include patients with relapsed or refractory low grade follicular transformed CD20-positive non-Hodgkin's lymphoma who have not received rituximab |
|
美元
|
| |
Clolar
clofarabine |
2004/12/28
Genzyme |
1～21岁儿童顽固性或复发性急性淋巴细胞白血病（ALL）
|
4×20毫升/盒 |
8,492美元
|
| |
Clolar
clofarabine |
Dec 28 2004
Genzyme |
Accel. Approv. (clinical benefit not established) for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens |
4×20毫升/盒 |
8,492美元
|
| |
Emend
APREPITANT |
2004/04/？？
默克公司 |
治疗化疗病人的恶心、呕吐 |
TRIFOLD PACK |
320美元
|
40毫克/胶囊
40胶囊/盒 |
美元
|
80胶囊/盒
40胶囊/盒 |
美元
|
125胶囊/盒
40胶囊/盒 |
美元
|
| 2003年期间 |
|
Femara
letrozole |
Jan 17 2003
Novartis |
|
|
美元
|
| |
Gliadel
carmustine |
Feb 25 2003
MGI Pharma |
Treatment of patients with malignant glioma undergoing primary surgical resection |
|
美元
|
| |
Gleevec
imatinib mesylate
（同时，见May 10 2001、Feb 01 2002、Feb 01 2002、Dec 20 2002、Apr 18 2003、May 20 2003、Dec 08 2003、Sep 27 2006、Oct 19 2006） |
Apr 18 2003
Novartis |
Accel. Approv. (clinical benefit not established) for treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in chronic phase. Follow-up is limited. Gleevec is also indicated for the treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival in patients with CML blast crisis, accelerated phase or chronic phase after failure of alpha interferon. Gleevec is also indicated for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST) |
|
美元
|
| |
Iressa
gefitinib |
May 05 2003
AstraZenca |
Accel. Approv. (clinical benefit not established ) as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies |
|
美元
|
| |
Adriamycin PFS
doxorubicin |
May 08 2003
Pharmacia |
For use in combination with cyclophosphamide as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer |
|
美元
|
| |
Velcade
bortezomib |
May 13 2003
Millenium |
Accel. Approv. (clinical benefit not established) for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy |
|
美元
|
| |
Gleevec
imatinib mesylate
（同时，见May 10 2001、Feb 01 2002、Feb 01 2002、Dec 20 2002、Apr 18 2003、May 20 2003、Dec 08 2003、Sep 27 2006、Oct 19 2006） |
May 20 2003
Novartis |
Accel. Approv. (clinical benefit not established) Treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. |
|
美元
|
| |
Bexxar
Tositumomab |
Jun 27 2003
Corixa Corporation |
Accel. Approv. (clinical benefit not established) Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy |
|
美元
|
| |
Photofrin
porfimer sodium |
Aug 01 2003
Axcan Scandipharm |
For the ablation of high-grade dysplasia in Barrett’s esophagus patients who do not undergo esophagectomy |
|
美元
|
| |
abarelix
Plenaxis depot |
Nov 25 2003
Praecis |
For the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia |
|
美元
|
| |
Gleevec
imatinib mesylate
（同时，见May 10 2001、Feb 01 2002、Feb 01 2002、Dec 20 2002、Apr 18 2003、May 20 2003、Dec 08 2003、Sep 27 2006、Oct 19 2006） |
Dec 08 200
Novartis |
Conversion to regular approval for treatment of patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy |
|
美元
|
| 2002年期间 |
| |
Eligard
Leuprolide Acetate |
Jan 23 2002
QLT USA |
palliative treatment of advanced prostate cancer. |
|
美元
|
| |
Neulasta
Pegfilgrastim |
Jan 31 2002
Amgen, Inc |
Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. |
|
美元
|
| |
Gleevec
Imatinib mesylate |
Feb 01 2002
Novartis |
Accel. Approv. (clinical benefit not established) Treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). |
|
美元
|
| |
Gleevec
imatinib mesylate |
Feb 01 2002
Novartis |
Accel. Approv. (clinical benefit not established) metastatic or unresectable malignant gastrointestinal stromal tumors |
|
美元
|
泽瓦林
替伊莫单抗 |
Zevalin
Ibritumomab Tiuxetan |
2002/02/19
IDEC Pharmaceuticals Corp |
Accel. Approv. (clinical benefit not established) treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab refractory follicular non-Hodgkin’s lymphoma.
治疗对Rituxan（rituximab）耐药的低分化非何杰金氏淋巴瘤 |
|
美元
|
择泰
唑来磷酸 |
ZOMETA
ZOLEDRONIC ACID |
2002/02/22
Novartis
诺华 |
the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy |
4毫克/5毫升/瓶非专利药GENERIC |
378.00美元
|
| mesna |
Mesnex tabs |
Mar 21 2002
Baxter |
Reducing the incidence of ifosfamide-induced hemorrhagic cystitis |
|
美元
|
| |
Faslodex
fulvestrant |
Apr 25 2002
IPR |
the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy |
|
美元
|
| |
Intron A Intron A
Interferon alfa-2b |
Jun 21 2002
Schering Corp |
|
|
美元
|
| |
Elitek
Rasburicase |
Jul 12 2002
Sanofi-Synthelabo, Inc |
ELITEK is indicated for the initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. |
|
美元
|
| |
Aranesp
Darbepoetin alfa |
Jul 19 2002
Amgen, Inc |
Aranesp is indicated for the treatment of anemia in patients with non- myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. |
|
美元
|
| |
Elspar
Asparaginase |
Aug 01 2002
Merck & Co, Inc |
ELSPAR is indicated in the therapy of patients with acute lymphocytic leukemia. This agent is useful primarily in combination with other chemotherapeutic agents in the induction of remissions of the disease in pediatric patients.
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|
美元
|
| |
Eloxatin
oxaliplatin |
Aug 09 2002
Sanofi Synthelabo |
Accel. Approv. (clinical benefit not established) in combination with infusional 5-FU/LV, is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan. |
|
美元
|
| |
Herceptin
Trastuzumab
（同时，见Nov 16 2006、Sep 25 1998、Feb 09 2000、Aug 28 2002、Aug 28 2002） |
Aug 28 2002
Genentech, Inc |
|
|
美元
|
| |
Herceptin
Trastuzumab
（同时，见Nov 16 2006、Sep 25 1998、Feb 09 2000、Aug 28 2002、Aug 28 2002） |
Aug 28 2002
Genentech, Inc
|
|
|
美元
|
| |
Arimidex
anastrozole |
Sep 05 2002
AstraZeneca |
Accel. Approv. (clinical benefit not established) for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer |
|
美元
|
| |
Neumega
Oprelvekin |
Sep 18 2002
Genetics Institute, Inc |
|
|
美元
|
| |
Neumega
Oprelvekin |
Sep 18 2002
Genetics Institute, Inc |
Neumega is indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia. |
|
美元
|
| |
Zinecard
dexrazoxane |
Oct 31 2002
Pharmacia & Upjohn Company |
Conversion to regular approval for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. It is not recommended for use with the initiation of doxorubicin therapy. |
|
美元
|
| |
Navelbine
vinorelbine |
Nov 05 2002
GlaxoSmithKline |
Navelbine is indicated as a single agent or in combination with cisplatin for the first-line treatment of ambulatory patients with unreseactable, advanced non-small cell lung cancer (NSCLC). In patients with Stage IV NSCLC, Navelbine is indicated as a single agent or in combination with cisplatin. In Stage III NSCLC, Navelbine is indicated in combination with cisplatin. |
|
美元
|
| |
Mitozytrex
mitomycin C |
Nov 14 2002
Supergen |
therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. |
|
美元
|
| |
Taxotere
docetaxel |
Nov 27 2002
Aventis Pharmaceutical |
for use in combination with cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition cisplatin for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. |
|
美元
|
| |
Gleevec
imatinib mesylate |
Dec 20 2002
Novartis |
Accel. Approv. (clinical benefit not established) Initial treatment of newly diagnosed Ph+ chronic myelogenous leukemia (CML). |
|
美元
|
| 2001年期间 |
| |
Femara
letrozole |
Jan 10 2001
Novartis |
First-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.
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|
美元
|
| |
Xeloda
capecitabine |
Apr 30 2001
Roche |
Initial therapy of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5_FU/LV has not been demonstrated with Xeloda monotherapy. |
|
美元
|
| |
Campath
Alemtuzumab |
May 07 2001
Millennium and ILEX Partners, LP |
Accel. Approv. (clinical benefit not established) Campath is indicated for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy. |
|
美元
|
| |
Gleevec
imatinib mesylate |
May 10 2001
Novartis |
Accel. Approv. (clinical benefit not established) Initial therapy of chronic myelogenous leukemia |
|
美元
|
| 择泰 |
Zometa
zoledronic acid |
Aug 20 2001
Novartis |
Treatment of hypercalcemia of malignancy |
4毫克/5毫升/瓶
非专利药GENERIC |
378美元
|
| |
Xeloda
capecitabine |
Sep 07 2001
Roche |
Conversion to regular approval for treatment in combination with docetaxel of patients with metastatic breast cancer after failure of prior anthracycline containing chemotherapy |
|
美元
|
| |
Aranesp
Darbepoetin alfa |
Sep 17 2001
Amgen, Inc |
Treatment of anemia associated with chronic renal failure. |
|
美元
|
| 2000年期间 |
| |
Herceptin
Trastuzumab
（同时，见Nov 16 2006、Sep 25 1998、Feb 09 2000、Aug 28 2002、Aug 28 2002） |
Feb 09 2000
Genentech, Inc |
Herceptin in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER-2 protein and had not received chemotherapy for their metastatic disease |
|
美元
|
| |
Camptosar
irinotecan |
Apr 20 2000
Pharmacia & Upjohn Company |
For first line treatment n combination with 5-FU/leucovorin of metastatic carcinoma of the colon or rectum. |
|
美元
|
| |
Mylotarg
gemtuzumab ozogamicin |
May 17 2000
Wyeth Ayerst |
Accel. Approv. (clinical benefit not established) Treatment of CD33 positive acute myeloid leukemia in patients in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy. |
|
美元
|
| |
Taxol
paclitaxel |
Jun 20 2000
Bristol-Myers Squibb |
First line ovarian cancer with 3 hour infusion. |
|
美元
|
| |
Targretin
bexarotene gel |
Jun 28 2000
Ligand Pharmaceuticals |
For the topical treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. |
|
美元
|
| |
Nolvadex
tamoxifen |
Jun 29 2000
AstraZeneca Pharmaceuticals |
In women with DCIS, following breast surgery and radiation, Nolvadex is indicated to reduce the risk of invasive breast cancer. |
|
美元
|
| |
Arimidex
anastrozole |
Sep 01 2000
AstraZeneca Pharmaceuticals |
For first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. |
|
美元
|
| |
Trisenox
arsenic trioxide |
Sep 25 2000
Cell Therapeutic |
Second line treatment of relapsed or refractory APL following ATRA plus an anthracycline. |
|
美元
|
| 1999年期间 |
| |
Panretin
alitretinoin |
Feb 02 1999
Ligand Pharmaceuticals |
Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. |
|
美元
|
| |
Busulfex
busulfan intravenous |
Feb 04 1999
Orphan Medical, Inc |
Use in combination with cyclophoshamide as conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. |
|
美元
|
| |
Ontak Denileukin diftitox |
Feb 05 1999
Seragen, Inc |
Accel. Approv. (clinical benefit not established) treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor |
|
美元
|
| |
Uvadex
methoxsalen |
Feb 25 1999
Therakos |
For the use of UVADEX with the UVAR Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. |
|
美元
|
| |
DepoCyt
cytarabine liposomal |
Apr 01 1999
Skye Pharmaceuticals |
Accel. Approv. (clinical benefit not established) Intrathecal therapy of lymphomatous meningitis |
|
美元
|
| |
Ethyol
amifostine |
Jun 24 1999
US Bioscience |
To reduce post-radiation xerostomia for head and neck cancer where the radiation port includes a substantial portion of the parotid glands. |
|
美元
|
| |
Doxil
doxorubicin liposomal |
Jun 28 1999
Sequus Pharmaceuticals, Inc. |
Accel. Approv. (clinical benefit not established) Treatment of metastatic carcinoma of the ovary in patient with disease that is refractory to both paclitaxel and platinum based regimens |
|
美元
|
| |
epogen
Epoetin alfa |
Jul 26 1999
Amgen, Inc |
EPOGENB is indicated for the reatment of anemia related to therapy with zidovudine in HIV- infected patients. EPOGENB is indicated to elevate or maintain the red blood cell level (as manifested by the hematocrit or hemoglobin determinations) and to decrease the need for transfusions in these patients. EPOGEND is not indicated for the treatment of anemia in HIV-infected patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately.
EPOGENB is indicated for the treatment of anemic patients (hemoglobin > 10 to _< 13 g/dL) scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions.
EPOGENB is indicated for the treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy. EPOGEND is indicated to decrease the need for transfusions in patients who will be receiving concomitant chemotherapy for a minimum of 2 months. EPOGENB is not indicated for the treatment of anemia in cancer patients due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding, which should be managed appropriately. |
|
美元
|
特莫达
替莫唑胺 |
TEMODAR
TEMOZOLOMIDE |
1999/8/11
Schering-plough公司 |
成人恶性神经胶质瘤和恶性黑色素瘤 |
5毫克/胶囊
14胶囊/盒 |
3227美元
|
5毫克/胶囊
20胶囊/盒 |
美元
|
20毫克/胶囊
5胶囊/盒 |
美元
|
20毫克/胶囊
14胶囊/盒 |
美元
|
20毫克/胶囊
20胶囊/盒 |
美元
|
100毫克/胶囊
5胶囊/盒 |
美元
|
100毫克/胶囊
14胶囊/盒 |
美元
|
100毫克/胶囊
20胶囊/盒 |
美元
|
40毫克/胶囊
5胶囊/盒 |
美元
|
140毫克/胶囊
14胶囊/盒 |
美元
|
180毫克/胶囊
5胶囊/盒 |
美元
|
180毫克/胶囊
14胶囊/盒 |
美元
|
250毫克/胶囊
5胶囊/盒 |
美元
|
250毫克/胶囊
10胶囊/盒 |
美元
|
| |
Temodar
temozolomide |
Aug 11 1999
Schering |
Accel. Approv. (clinical benefit not established) Treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse with disease progression on a nitrosourea and procarbazine containing regimen |
|
美元
|
| |
Ellence
epirubicin |
Sep 15 1999
Pharmacia & Upjohn Company |
A component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. |
|
美元
|
| |
Aromasin
exemestane |
Oct 21 1999
Pharmacia & Upjohn Company |
Treatment of advance breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. |
|
美元
|
| |
Taxol
paclitaxel |
Oct 25 1999
Bristol-Myers Squibb |
For the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination therapy. |
|
美元
|
| |
Celebrex
celecoxib |
Dec 23 1999
Searle |
Accel. Approv. (clinical benefit not established) Reduction of polyp number in patients with the rare genetic disorder of familial adenomatous polyposis. |
|
美元
|
| |
Taxotere
docetaxel |
Dec 23 1999
Aventis Pharmaceutical |
For locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
|
|
美元
|
| |
Targretin
bexarotene capsules |
Dec 29 1999
Ligand Pharmaceuticals |
For the treatment by oral capsule of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy. |
|
美元
|
| 1998年期间 |
| |
Prokine
aldesleukin |
Jan 09 1998
Chiron |
Treatment of adults with metastatic melanoma |
|
美元
|
| |
Photofrin
porfimer sodium |
Jan 09 1998
QLT Phototherapeutics Inc. |
For use in photodynamic therapy for treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated. |
|
美元
|
| |
Daunorubicin
daunorubicin, daunomycin |
Jan 30 1998
Bedford Labs |
Leukemia/myelogenous/monocytic/erythroid of adults/remission induction in acute lymphocytic leukemia of children and adults. |
|
美元
|
| |
Hydrea
hydroxyurea |
Feb 25 1998
Bristol-Myers Squibb |
Decrease need for transfusions in sickle cell anemia |
|
美元
|
| |
Etopophos
etoposide phosphate |
Feb 27 1998
Bristol-Myers Squibb |
Management of refractory testicular tumors and small cell lung cancer. |
|
美元
|
| |
Neupogen
Filgrastim |
Apr 02 1998
Amgen, Inc |
NEUPOGEN is indicated to decrease the incidence of infection? as manifested by febrile neutropenia? in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever.
NEUPOGEN is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation hemotherapy treatment of adults with AML.
NEUPOGEN is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae, eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation. |
|
美元
|
| |
Taxol
paclitaxel |
Apr 09 1998
Bristol-Myers Squibb |
For first-line therapy for the treatment of advanced carcinoma of the ovary in combination with cisplatin.
|
|
美元
|
| |
Xeloda
capecitabine |
Apr 30 1998
Roche |
Accel. Approv. (clinical benefit subsequently established) Treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents |
|
美元
|
| |
Taxotere
docetaxel |
Jun 22 1998
Aventis Pharmaceutical |
Conversion to regular approval - treatment of locally advanced or metastatic breast cancer which has progressed during anthracycline-based treatment or relapsed during anthracycline-based adjuvant therapy. |
|
美元
|
| |
Taxol
paclitaxel |
Jun 30 1998
Bristol-Myers Squibb |
for use in combination with cisplatin, for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. |
|
美元
|
| |
TICE BCG
BCG Live |
Aug 21 1998
Organon Teknika Corp |
|
|
美元
|
| |
Gemzar
gemcitabine |
Aug 25 1998
Eli Lilly |
For use in combination with cisplatin for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer. |
|
美元
|
| |
Aredia
pamidronate |
Sep 22 1998
Novartis |
Treatment of osteolytic bone metastases of breast cancer in conjunction with standard antineoplastic therapy. |
|
美元
|
| |
Herceptin
Trastuzumab
（同时，见Nov 16 2006、Sep 25 1998、Feb 09 2000、Aug 28 2002、Aug 28 2002） |
Sep 25 1998
Genentech, Inc |
HERCEPTIN as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. |
|
美元
|
| |
Valstar
valrubicin |
Sep 25 1998
Anthra --> Medeva |
For intravesical therapy of BCG-refractory carcinoma in situ (CIS) of the urinary bladder in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. |
|
美元
|
| |
Camptosar
irinotecan |
Oct 22 1998
Pharmacia & Upjohn Company |
Conversion to regular approval - treatment of metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. |
|
美元
|
| |
Nolvadex
tamoxifen |
Oct 29 1998
AstraZeneca Pharmaceuticals |
to reduce the incidence of breast cancer in women at high risk for breast cancer |
|
美元
|
| |
Hycamtin
topotecan |
Nov 30 1998
GlaxoSmithKline |
Treatment of small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy |
|
美元
|
| |
Photofrin
porfimer sodium |
Dec 22 1998
QLT Phototherapeutics Inc. |
For use in photodynamic therapy (PDT) for reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobroncial nonsmall cell lung cancer (NSCLC).
|
|
美元
|
| 1997年期间 |
| |
Idamycin
idarubicin |
Feb 17 1997
Pharmacia & Upjohn Company |
In combination with other approved antileukemic drugs for the treatment of acute non-lymphocytic leukemia in adults. |
|
美元
|
| |
Fareston
toremifene |
May 29 1997
Orion Corp. |
Treatment of advanced breast cancer in postmenopausal women. |
|
美元
|
| |
Femara
letrozole |
Jul 25 1997
Novartis |
Treatment of advanced breast cancer in postmenopausal women. |
|
美元
|
| |
Taxol
paclitaxel |
Aug 04 1997
Bristol-Myers Squibb |
second line therapy for AIDS related Kaposi's sarcoma. |
|
美元
|
| |
Intron A
Interferon alfa-2b |
Nov 06 1997
Schering Corp |
Interferon alfa-2b, recombinant for Injection is indicated for the initial treatment of clinically aggressive follicular non-Hodgkin’s Lymphoma in conjunction with anthracycline-containing combination chemotherapy in patients 18 years of age or older. |
|
美元
|
| |
Neumega
Oprelvekin |
Nov 25 1997
Genetics Institute, Inc |
Prevention of severe thrombocytopenia following myelosuppressive chemotherapy |
|
美元
|
| |
Rituxan
Rituximab |
Nov 26 1997
Genentech, Inc |
Treatment of patients with relapsed or refractory low-grade or follicular B-cell non-Hodgkin's lymphoma |
|
美元
|
| |
Paxene
paclitaxel |
Dec 24 1997
Baker Norton Pharmaceuticals, Inc |
treatment of advanced AIDS-related Kaposi's sarcoma after failure of first line or subsequent systemic chemotherapy |
|
美元
|
| |
Sclerosol
talc |
Dec 24 1997
Bryan |
For the prevention of the recurrence of malignant pleural effusion in symptomatic patients. |
|
美元
|
