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ID号：675 发布日期： 2013-08-28 截止日期： 不限 地区： 全国
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Drugs Approved in 2013
Kadcyla (ado-trastuzumab emtansine); Genentech; For the treatment of HER2-positive metastatic breast cancer, Approved February 2013
Pomalyst (pomalidomide); Celgene; For the treatment of relapsed and refractory multiple myeloma, Approved February 2013
Stivarga (regorafenib); Bayer Healthcare Pharmaceuticals; For the treatment of gastrointestinal stromal tumor, Approved February 2013
Drugs Approved in 2012
Afinitor (everolimus); Novartis; For the treatment of hormone receptor-positive, HER2-negative breast cancer, Approved July 2012
Abraxane (paclitaxel protein-bound particles for injectable suspension); Celgene; For the treatment of non-small cell lung cancer, Approved October 2012
Afinitor (everolimus); Novartis Pharmaceuticals Corporation; For the treatment of renal angiomyolipoma associated with tuberous sclerosis complex, Approved April 2012
Bosulif (bosutinib); Pfizer; For the treatment of Ph+ chronic myelogenous leukemia, Approved September 2012
Cometriq (cabozantinib); Exelixis; For the treatment of metastatic medullary thyroid cancer, Approved November 2012
Iclusig (ponatinib); Ariad Pharmaceuticals; For the treatment of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia, Approved December 2012
Erivedge (vismodegib); Genentech; For the treatment of basal cell carcinoma, Approved January 2012
Inlyta (axitinib); Pfizer; For the treatment of advanced renal cell carcinoma, Approved January 2012
Kyprolis (carfilzomib); Onyx Pharmaceuticals; For the treatment of multiple myeloma, Approved July 2012
Marqibo (vinCRIStine sulfate LIPOSOME injection); Talon Therapeutics; For the treatment of Ph- acute lymphoblastic leukemia, Approved August 2012
Neutroval (tbo-filgrastim); Teva Pharmaceuticals; For the reduction in the duration of severe chemotherapy-induced neutropenia, Approved August 2012
Perjeta (pertuzumab); Genentech; For the first-line treatment of HER2+ metastatic breast cancer, Approved June 2012
Picato (ingenol mebutate) gel; LEO Pharma; For the treatment of actinic keratosis, Approved January 2012
Stivarga (regorafenib); Bayer HealthCare Pharmaceuticals; For the treatment of previously treated patients with metastatic colorectal cancer, Approved September 2012
Subsys (fentanyl sublingual spray); Insys Therapeutics; For the treatment of breakthrough cancer pain, Approved January of 2012
Synribo (omacetaxine mepesuccinate); Teva Pharmaceuticals; For the treatment of chronic or accelerated phase chronic myeloid leukemia, Approved October 2012
Votrient (pazopanib); GlaxoSmithKline; For the treatment of soft tissue sarcoma, Approved April 2012
Xtandi (enzalutamide); Medivation; For the treatment of metastatic castration-resistant prostate cancer, Approved August 2012
Zaltrap (ziv-aflibercept); Sanofi Aventis US; For the treatment of metastatic colorectal cancer, Approved August 2012
Drugs Approved in 2011
Abstral (fentanyl sublingual tablets); ProStrakan; For the treatment of breakthrough cancer pain in opioid-tolerant patients, Approved January 2011
Adcretris (brentuximab vedotin); Seattle Genetics; For the treatment of Hodgkin lymphoma and anaplastic large cell lymphoma, Approved August 2011
Afinitor (everolimus); Novartis; For the treatment of advanced pancreatic neuroendocrine tumors, Approved May 2011
Erwinaze (asparaginase Erwinia chrysanthemi); Eusa Pharma; For the treatment of acute lymphoblastic leukemia, Approved November of 2011
Lazanda (fentanyl citrate) nasal spray; Archimedes; For the management of breakthrough cancer pain, Approved June 2011
Sutent (sunitinib malate); Pfizer; For the treatment of pancreatic neuroendocrine tumors, Approved May 2011
Sylatron (peginterferon alfa-2b); Merck; For the treatment of melanoma, Approved April 2011
Vandetanib (vandetanib); Astra Zeneca; For the treatment of thyroid cancer, Approved April 2011
Xalkori (crizotinib); Pfizer; For the treatment of ALK+ non-small cell lung cancer, Approved August of 2011
Yervoy (ipilimumab); Bristol-Myers Squibb; For the treatment of metastatic melanoma, Approved March 2011
Zelboraf (vemurafenib); Roche; For the treatment of BRAF + melanoma, Approved August of 2011
Zytiga (abiraterone acetate); Centocor Ortho Biotech; For the treatment of prostate cancer, Approved May
Drugs Approved in 2010
Halaven (eribulin mesylate); Eisai; For the treatment of metastatic breast cancer, Approved November 2010
Herceptin (trastuzumab); Genentech; For the treatment of gastric cancer, Approved October 2010
Jevtana (cabazitaxel); sanofi aventis; For the treatment of prostate cancer, Approved June 2010
Provenge (sipuleucel-T); Dendreon; For the treatment of hormone refractory prostate cancer, Approved May 2010
Xgeva (denosumab); Amgen; For the prevention of skeletal-related events in patients with bone metastases from solid tumors, Approved November 2010
Zuplenz (ondansetron oral soluble film); Strativa Pharmaceuticals; For the prevention of post-operative, chemotherapy and radiotherapy induced nausea and vomiting, Approved July 2010
Drugs Approved in 2009
Afinitor (everolimus); Novartis; 肾癌新药, Approved March 2009
Arzerra (ofatumumab); GlaxoSmithKline; 治疗慢性淋巴细胞性白血病, Approved October 2009
Avastin (bevacizumab); Genentech; 肾癌新药, Approved July 2009
Cervarix [Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant; GlaxoSmithKline; 预防由人乳头状瘤16-18病毒引起的宫颈癌和宫颈上皮细胞瘤, Approved October 2009
Elitek (rasburicase); sanofi-aventis; 用于控制恶性尿酸血症的血浆尿酸水平s, Approved October 2009
Folotyn (pralatrexate injection); Allos Therapeutics; 治疗周围T-淋巴细胞淋巴瘤, Approved September 2009
Istodax (romidepsin); Gloucester Pharmaceuticals; For the treatment of 皮肤T-细胞淋巴瘤, Approved November 2009
Onsolis (fentanyl buccal); BioDelivery Sciences; 治疗癌痛, Approved July 2009
Votrient (pazopanib); GlaxoSmithKline; 治疗肾癌, Approved October of 2009
Drugs Approved in 2008
Treanda (bendamustine hydrochloride) ; 治疗慢性淋巴细胞性白血病; Cephalon; Approved 2008年3月
Fusilev (levoleucovorin); Spectrum Pharmaceuticals; 用于高剂量氨甲喋呤治疗的急救和减少其毒性, Approved March of 2008
Mozobil (plerixafor injection); Genzyme; 治疗非何杰金氏淋巴瘤以及多发性骨髓瘤, Approved December 2008
Degarelix (degarelix for injection); Ferring Pharmaceuticals; 前列腺癌新药, Approved December of 2008
Sancuso (granisetron); ProStrakan; 治疗化疗引起的恶心， 呕吐, Approved September 2008
Drugs Approved in 2007
Hycamtin (topotecan) ; 治疗小细胞肺癌 晚期子 宫颈癌 卵巢癌 ,GlaxoSmithKline; Approved October 2007
Ixempra (ixabepilone) ; 通过FDA的批准用 作一线药物治疗晚期乳腺癌; Bristol Myers Squibb; Approved October 2007
Tykerb (lapatinib) ; 乳腺癌晚期新药 Tykerb,是葛兰素史克公司研制的。 临床试验显示,对于那些已对罗氏的赫赛汀(Herceptin)产生耐药性的HER2型乳癌患者,这种新药有很好的临床效果。
Torisel (temsirolimus) ; 晚期肾癌最新药物， 是唯一上市的特异性抑制mTOR激酶的药物,mTOR激酶是调节细胞增值、生长和细胞存活重要的蛋白质。能够有效抑制和调节蛋白细胞增殖、细胞生长和细胞 存活率,是目前第一剂用于治疗癌症的注射剂。
Tasigna (nilotinib hydrochloride monohydrate) ; 治疗慢性骨髓性白血病的新药 Novartis; 2007年10 月批准上市
vista (raloxifene hydrochloride) ; 治疗和预防骨质疏松以及减少绝经期妇女乳腺癌的发生；Eli Lilly; 2007年9 月批准上市。
Drugs Approved in 2006
Sutent (sunitinib) ; 治疗肾细胞肿瘤和胃肠道间质肿瘤新药。Pfizer生产; 2006年1月批准上市。
Sprycel(dasatinib) ; 用于治疗两种新的适应症：对伊马替尼等一线药物化疗不敏感的各期慢性粒细胞白血病(CML)，以及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)。
Vectibix (panitumumab) 协助治疗大肠直肠癌已扩散到其它部位的患者 。 对肿瘤有减 缓恶化的效用 (在某些病例甚至能缩小肿瘤)
Drugs Approved in 2005
Arranon (nelarabine) ; 治疗急性成淋巴细胞性白血病 T细胞淋巴瘤新药 GlaxoSmithKline生产; 2005年10 月批准上市。
Nexavar (sorafenib) ; 全球首个口服多激酶抑制剂，治疗晚期肾细胞癌的药物，Bayer/Onyx生产; 2005年12 月批准上市。
Revlimid (lenalidomide) ; 治疗轻中度-1-risk 骨髓增生异常综合征合; Celgene生产; 2005年12月批准上市。
Abraxane ( PACLITAXEL PROTEIN-BOUND ) ; 美国制药伙伴公司(American Pharmaceutical Partners,APP)和美国生物科学(American BioScience)近日宣布，美国FDA批准了Abraxane用于治疗转移性乳腺癌的新药申请。两家公司利用他们的专利纳米技术,把Abraxane的活性成分紫杉醇(Paclitaxel)和只有红细胞1%大小的纳米白蛋白颗粒结合在一起，从而避免了各种溶解可能。Abraxane是第一非溶解纳米白蛋白结合化疗药物，可以有效的利用白蛋白受体内在途径传输药物通过肿瘤新生血管内皮细胞壁。与单纯紫杉醇相比，其作用时间长，副作用小。
Drugs Approved in 2004
Alimta (pemetrexed for injection) ; 治疗恶性胸膜间皮瘤，li Lilly 生产; 2004年二月批准上市
Avastin (bevacizumab) ; 治疗恶性直肠癌; Genentech生产; 2004年2月批准上市
Erbitux (cetuximab) ; 治疗EGFR-表现的恶性结肠直肠癌; Imclone / Bristol-Myers Squibb生产; 2004年二月批准上市
Sensipar (cinacalcet) ; 治疗继发性甲状旁腺功能抗进(甲状旁腺癌)引起的高血钙; Amgen生产; 2004年三月批准上市
Clolar (clofarabine) ; 用于治疗小儿急性淋巴细胞性白血病; Genzyme; 生产; 2004年12月批准上市
Tarceva (erlotinib, OSI 774) ; 用于治疗恶性，难治性非小细胞肺癌; Genentech, OSI Pharmaceuticals生产; 2004年11月批准上市
Drugs Approved in 2003
Emend (aprepitant) ; 治疗化疗病人的恶心，呕吐; Merck生产; 2003年3月批准上市
Iressa (gefitinib) ; 治疗非小细胞肺癌的新药，AstraZeneca生产; 2003年5月批准上市
Aloxi (palonosetron) ; 预防肿瘤化疗病人的恶心，呕吐 ; MGI Pharma / Helsinn Healthcare研发生产; 2003年8月批准上市
UroXatral (alfuzosin HCl extended-release tablets);治疗良性前列腺增生的各种症状; Sanofi-Synthelabo生产; 2003年6月批准上市
Velcade (bortezomib) ; 治疗至少接受过二种以上疗法的多发性骨髓瘤得病人; Millennium Pharmaceuticals生产; 2003年5月批准上市
exxar ; 治疗CD20阳性，的小囊性非霍杰金氏淋巴瘤化疗复发的病人; Corixa生产; 2003年6月批准上市
Drugs Approved in 2002
Eligard (leuprolide acetate) ; 前列腺癌抗癌新疗法 用于前列腺癌的缓解治疗 ; Atrix Laboratories; 2002年 1 月批准 上市 Eloxatin (oxaliplatin/5-fluorouracil/leucovorin); 用于结肠和直肠癌症的治疗 ; Sanofi-Synthelabo生产; 2002年8月批准 上市 Faslodex (fulvestrant) ; 治疗激素受体阳性的代谢转移性乳腺癌; AstraZeneca生产; 2002年4月批准 上市
Gleevec ; 治疗血癌 ( 慢性骨髓性白血病) chronic myelogenous leukemia (CML) 非常有效，并对治疗胃肠基底细胞癌 (gastrointestinal stromal tumor) (GIST) 、前列腺癌等亦有明显效果 ; 由 Novartis 开发生产 ; 2002 年 2 月批准 胃肠癌新适应症
Neulasta ; 降低由于化疗引起的中性白细胞减少症而导致的感染机会 Amgen; 2002年1月批准 上市
SecreFlo (secretin) ; 用于胰腺功能诊断和治疗胃泌素肿瘤; Repligen; 2002年4月批准 上市
Zevalin (ibritumomab tiuxetan) ; 治疗非霍杰金氏淋巴肉瘤 ; IDEC Pharmaceuticals; 2002 年 2 月批准 上市
Zometa (zoledronic acid) ; 治疗多发性骨髓瘤 实体肿瘤导致的 骨坏死 ; Novartis; 2002 年 2 月批准 上市
Drugs Approved in 2001
Campath ; 注射用药治疗B-细胞慢性淋巴性白血病; 由Berlex Laboratories 开发生产 ; 2001年5月批准上市
Femara (letrozole) 片剂; 停经后妇女罹患转移性乳癌的第一线治疗药物; 由Novartis 开发生产 ; 2001年1月批准上市
Gleevec ; 治疗血癌 ( 慢性骨髓性白血病) chronic myelogenous leukemia (CML) 非常有效，并对治疗胃肠基底细胞癌 (gastrointestinal stromal tumor) (GIST) 、前列腺癌等亦有明显效果 ; 由Novartis 开发生产 ; 2001年5月批准上市
Kytril (granisetron) Solution ; 化疗病人的恶心，呕吐; Hoffmann-La Roche生产; 2001年6月批准上市
Trelstar LA ; 肌肉注射针剂，老年前列腺癌症治疗; Debiopharm S.A.;生产; 2001年6月批准上市
Xeloda ; 直肠结肠癌症口服化疗药; Hoffman-La Roche生产; 2001年5月批准上市
Zometa (zoledronic acid) ; 用于恶性高血钙症的治疗For the treatment of hypercalcemia of malignancy; Novartis生产; 2001年8月批准上市
Drugs Approved in 2000
Mylotarg ( gemtuzumab ozogamicin) ; CD33 阳性的急性髓性白血病(AML); Wyeth生产; 2000年5月批准上市
Trelstar Depot (Injectable Triptorelin Pamoate) ; 进行性前列腺癌姑息疗法 ; Debio Rechereche Pharmaceutique SA (c/o Target Research Associates)生产; 2000年6月批准上市
Trisenox (arsenic trioxide) ; 一种含砷的药物，也就是我们俗称 的砒霜，可以用来治疗一个致命性的罕见疾病─急性前骨随细胞性白血病 ，这是美国近百年来首次核准的砷疗法。适应成年患者的复发/顽固型急性早幼粒细胞白血病治疗(APL)Cell Therapeutics 生产; 2000年9月批准上市
Viadur (leuprolide acetate implant) ;用于 进行性前列腺癌疼痛缓解 ; ALZA Corporation生产; 2000年3月批准上市
Drugs Approved in 1999
Aromasin Tablets; Exemestane Tablets, 25 mg; 乳癌患者改服 AROMASIN 更有可能保持癌症不复发 Pharmacia & Upjohn生产; 1999年10月批准上市
Busulflex ; 合并用于白血病的综合治疗 ; Orphan Medical, Inc.生产; 1999年2月批准上市
Doxil (doxorubicin HCl liposome injection); 治疗顽固性卵巢癌。适用于那些曾经用过当今一流的化疗方法医治过的顽固性卵巢癌患者。顽固性卵巢癌被定义为：在治疗过程中或完成治疗后6个月里病情不断恶化的疾病。Treatment for ovarian cancer that is refractory to other first-line therapies; Alza Corp.生产; 1999年6月批准上市;
Ellence ; epirubicin hydrochloride; 可 治 疗 早 期 由 乳 癌 扩 散 至 淋 巴 结 癌 肿 的 女 性Pharmacia & Upjohn生产; 1999年9月批准上市;
Ethyol (amifostine); 治疗肿瘤放疗病人的口腔干燥症(dry mouth); U.S. Bioscience and Alza Corp.生产; 1999年6月批准上市;
Temodar ; 治疗难治性退行性星状细胞瘤; Schering-Plough生产; 1999年8月批准上市;
UVADEX Sterile Solution; 治疗的皮肤T细胞淋巴瘤(Cutaneous T cell lymphoma, CTCL)的皮肤改变; Therakos, Inc.生产; 1999年2月批准上市;
Zofran ODT; 预防肿瘤化疗和放疗病人的恶心，呕吐; Glaxo Wellcome Inc.生产; 1999年1月批准上市;
Drugs Approved in 1998
Actiq ; 治疗癌症疼痛 Pain; Anesta Corporation生产; 1998年11月批准上市;
Anzemet ;治疗预防肿瘤化疗和手术病人的恶心，呕吐; 1998年2月批准上市
Camptosar ; 治疗直肠结肠癌症; Pharmacia & Upjohn生产; 1998年10月批准上市
Gemzar ; 治疗肺癌; Eli Lilly生产; 1998年8月批准上市
Herceptin ; 治疗恶性乳房癌; Genentech生产; 1998年10月批准上市
Neupogen ; 治疗肿瘤病人化疗后白细胞恢复缓慢; Amgen生产; 1998年4月批准上市
Nolvadex ; 治疗乳腺癌; Zeneca Pharmaceuticals生产; 1998年10月批准上市
Photofrin ; 治疗早期非小细胞肺癌 microinvasive endobronchial non-small cell lung cancer; QLT Therapeutics生产; 1998年1月批准上市
Proleukin ; 治疗代谢性黑色素瘤 Chiron Corporation生产; 1998年1月批准上市
Sclerosol Intrapleural Aerosol ; 治疗恶性胸腔积液; Bryan Corporation生产; 1998年1月批准上市
Valstar ; 治疗膀胱癌; Anthra Pharmaceuticals生产; 1998年10月批准上市
Xeloda ; 治疗进行性乳房癌瘤; Hoffmann LaRoche生产; 1998年4月批准上市
Zofran ; 治疗成年人手术后的恶心，呕吐; Glaxo Wellcome生产; 1998年4月批准上市
Drugs Approved in 1997
Anzemet ; Treatment for emesis; Hoechst Marion Roussel; Approved September 1997
Bromfenac ; Management of acute pain; Duract, Wyeth-Ayerst; Approved July 1997
Femara ; Treatment for breast cancer; Novartis; Approved July 1997
Gliadel Wafer (polifeprosan 20 with carmustine implant) ; Treatment for brain cancer; Rhone-Poulenc Rorer, Inc. and Guilford Pharmaceuticals Inc.; Approved February 1997
Intron A ; Treatment for non-Hodgkin's lymphoma; Schering-Plough Corp.; Approved December 1997
Kytril ; Prevention of nausea and vomiting associated with chemotherapy; SmithKline Beecham; Approved November 1997
Lupron Depot ; Treatment for prostate cancer; Tap Holdings; Approved July 1997
Miraluma test ; Test for breast cancer; DuPont Pharma Radiopharmaceuticals; Approved May 1997
Neumega ; Treatment for thrombocytopenia; Genetics Institute; Approved November 1997
Quadramet (Samarium Sm 153 Lexidronam Injection) ; Treatment for pain associated with bone cancer; DuPont Merck Pharmaceutical Company; Approved March 1997
Rituxan ; Treatment for non-hodgkin's lymphoma; Idec Pharmaceuticals; Genentech Inc.; Approved November 1997
Taxol ; Treatment for AIDS-related Kaposi's Sarcoma; Bristol-Myers Squibb; Approved August 1997
Drugs Approved in 1996
Anexsia ; Treatment for chronic pain; Mallinckrodt Group; Approved August 1996
Aredia (pamidronate disodium for injection) ; Treatment for osteolytic bone metastases of breast cancer; Chiron Therapeutics, Ciba Pharmaceuticals; Approved August 1996
Arimidex (anastrozole) ; Treatment for advanced breast cancer in postmenopausal women; Zeneca; Approved January 1996
Camptosar Injection ; Treatment for metastatic colorectal cancer; Pharmacia & Upjohn; Approved June 1996
CEA-Scan; Diagnostic imaging product for colorectal cancer; Immunomedics; Approved April 1996
Elliotts B Solution (buffered intrathecal electrolyte/dextrose injection) ; Treatment of meningeal leukemia or lymphocytic lymphoma; Orphan Medical, Inc.; Approved October 1996
Eulexin (flutamide) ; Treatment for prostate cancer; Schering-Plough Corporation; Approved June 1996
Feridex I.V. ; Contrast agent for magnetic resonance imaging of liver lesions; Advanced Magnetics; Approved February 1996
GastroMARK ; Contrast agent for magnetic resonance imaging of the gastrointestinal tract; Advanced Magnetics; Approved May 1996
Gemzar (Gemcitabine HCl) ; Treatment for pancreatic cancer; Eli Lilly; Approved May 1996
Hycamtin (topotecan hydrochloride) ; Treatment for metastatic ovarian cancer; SmithKline Beecham; Approved May 1996
Kadian ; Treatment for chronic moderate to severe pain; Purepac Pharmaceutical; Approved July 1996
Leukine (sargramostim) ; Treatment for the replenishment of white blood cells; Immunex Corporation; Approved November 1996
Lupron Depot (leuprolide acetate for depot suspension) ; Treatment for advanced prostate cancer; Abbott Laboratories; Approved January 1996
Photodynamic Therapy; Photodynamic therapy device for the treatment of esophageal cancer; Sanofi Winthrop, QLT PhotoTherapeutics; Approved January, 1996
Taxotere (Docetaxel) ; Treatment for locally advanced or metastatic breast cancer; Rhone Poulenc Rorer; Approved May 1996
UltraJect ; Treatment for chronic pain; Mallinckrodt Group; Approved August 1996
Visipaque (iodixanol) ; Diagnostic contrast agent; Nycomed; Approved April 1996
Zoladex (10.8 mg goserelin acetate implant) ; Treatment for advanced prostate cancer; Zeneca; Approved January 1996
Drugs Approved in 1995
Ethyol (amifostine) ; Treatment to reduce renal toxicity associated with chemotherapy in subjects with advanced ovarian cancer; Alza Pharmaceuticals, U.S. Bioscience; Approved December 8, 1995
Intron A (Interferon alfa-2b, recombinant) ; An adjuvant treatment to surgery in subjects at high risk for systemic recurrence of malignant melanoma; Schering-Plough; Approved December 1995
Leukine (sargramostim) ; Treatment for mobilizing peripheral blood progenitor cells for use after transplantation.; Immunex Corp.; Approved on November 24, 1995
Self-examination breast pad; Self-examination breast pad; Inventive Products Inc.; Approved on December 22, 1995
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