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桃花源记

铁杆木虫 (正式写手)

应助: 1 (幼儿园)
金币: 8823.8
散金: 21
红花: 2
帖子: 332
在线: 73.1小时
虫号: 285857
注册: 2006-10-14
专业: 药物材料

[交流] 2008年FDA 批准新药名单（截止11月底）

The following drugs have been approved this year by the Food and Drug Administration.

Cardiology/Vascular Diseases

Cleviprex (clevidipine); For the treatment of hypertension when oral therapy is not feasible or not desirable; The Medicines Company; Approved August 2008

Dental/Maxillofacial Surgery
No approvals recorded to date in this area.

Dermatology/Plastic Surgery
No approvals recorded to date in this area.

Endocrinology
Accretropin (somatropin rDNA Original); For the treatment of growth failure in pediatrics; Cangene Corp; Approved January 2008
Welchol (colesevelam hydrochloride); For the improvement of glycemic control in adults with type 2 diabetes mellitus; Daiichi Sankyo; Approved January 2008
Gastroenterology

Cimzia (Certolizumab Pegol); For the treatment of Crohn抯 disease; UCB Inc.; Approved April 2008
Entereg (alvimopan); For the treatment of postoperative ileus; GlaxoSmithKline; Approved May 2008
Rotarix (Rotavirus Vaccine, Live, Oral); For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics; GlaxoSmithKline; Approved April 2008
Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008
Tysabri (natalizumab); For the maintenance treatment of moderate to severe Crohn抯 disease; Biogen IDEC; Approved January 2008
Hematology

Nplate (romiplostim); For the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura; Amgen; Approved August 2008
Immunology/Infectious Diseases

Aptivus (tipranavir); For the treatment of HIV; Boehringer Ingelheim; Approved June 2008
Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008
Intelence (etravirine); For the treatment of HIV-1; Tibotec; Approved January 2008
Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
Rotarix (Rotavirus Vaccine, Live, Oral); For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics; GlaxoSmithKline; Approved April 2008
Tysabri (natalizumab); For the maintenance treatment of moderate to severe Crohn抯 disease; Biogen IDEC; Approved January 2008
Viread (tenofovir disoproxil fumarate); For the treatment of hepatitis B; Gilead; Approved August 2008
Musculoskeletal

Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008
Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008
Nephrology/Urology

Toviaz (fesoterodine fumarate); For the treatment of overactive bladder; Pfizer; Approved October 2008
Neurology

Banzel (rufinamide); For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults; Eisai; Approved November 2008
Durezol (difluprednate); For the treatment of inflammation and pain associated with ocular surgery; Sirion Therapeutics; Approved June 2008
Stavzor (valproic acid delayed release); For the treatment of bipolar manic disorder, seizures and migraine headaches; Banner Pharmacaps; Approved July 2008
Vimpat (lacosamide); For the treatment of partial-onset seizures in adults with epilepsy; Schwarz Pharma; Approved October 2008
Xenazine (tetrabenazine); For the treatment of chorea due to Huntington's disease; Prestwick Pharma; Approved August 2008

Obstetrics/Gynecology
No approvals recorded to date in this area.

Oncology
Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008
Treanda (bendamustine hydrochloride); For the treatment of Chronic lymphocytic leukemia and B-cell non-Hodgkin抯 lymphoma; Cephalon; Approved October 2008
Ophthalmology

Akten (lidocaine hydrochloride); For anesthesia during ophthalmologic procedures; Akorn; Approved October 2008
Durezol (difluprednate); For the treatment of inflammation and pain associated with ocular surgery; Sirion Therapeutics; Approved June 2008
Otolaryngology

Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
Patanase (olopatadine hydrochloride); For the treatment of seasonal allergic rhinitis; Alcon; Approved April 2008
Pediatrics/Neonatology

Accretropin (somatropin rDNA Original); For the treatment of growth failure in pediatrics; Cangene Corp; Approved January 2008
Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008
Aptivus (tipranavir); For the treatment of HIV; Boehringer Ingelheim; Approved June 2008
Banzel (rufinamide); For the treatment of seizures associated with Lennox-Gastaut syndrome in pediatrics and adults; Eisai; Approved November 2008
Cinryze (C1 Inhibitor (Human)); For the treatment of angioedema attacks in adolescents/adults with Hereditary Angioedema; Lev Pharmaceuticals; Approved October 2008
Moxatag (amoxicillin); For the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatrics; MiddleBrooke Pharmaceuticals; Approved January 2008
Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008
Patanase (olopatadine hydrochloride); For the treatment of seasonal allergic rhinitis; Alcon; Approved April 2008
Rotarix (Rotavirus Vaccine, Live, Oral); For the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in pediatrics; GlaxoSmithKline; Approved April 2008
Pharmacology/Toxicology

Akten (lidocaine hydrochloride); For anesthesia during ophthalmologic procedures; Akorn; Approved October 2008
Sancuso (granisetron); For the treatment of chemotherapy-induced nausea and vomiting; ProStrakan; Approved September 2008
Psychiatry/Psychology

Aplenzin (bupropion hydrobromide); For the treatment of major depressive disorder; Biovail Labs; Approved April 2008
Stavzor (valproic acid delayed release); For the treatment of bipolar manic disorder, seizures and migraine headaches; Banner Pharmacaps; Approved July 2008
Pulmonary/Respiratory Diseases

Alvesco (ciclesonide); For the maintenance treatment of asthma as prophylactic therapy in adults and adolescents; Nycomed; Approved January 2008
Patanase (olopatadine hydrochloride); For the treatment of seasonal allergic rhinitis; Alcon; Approved April 2008
Rheumatology

Orencia (abatacept); For the treatment of Juvenile Idiopathic Arthritis; Bristol-Myers Squibb; Approved April 2008

Trauma/Emergency Medicine
中文翻译（转自丁香园站友zhaoliangcai的翻译）
心血管疾病
氯维地平：治疗高血压，口服无效，The Medicines Co(MDCO)公司， 8月份批准

牙齿/颌面外科：无批准

皮肤/整形外科：无批准

内分泌：
Accretropin（生长激素原rDNA）：治疗小儿生长迟缓， Cangene Corp，1月份批准
Welchol（盐酸考来维仑）：2型糖尿病控制血糖，Daiichi Sankyo公司，1月份批准
Cimzia (聚乙二醇化人抗TNF-α抗体Fab片段)：治疗局限性肠炎，UCB公司，4月份批准
Entereg (阿片Mu受体拮抗剂alvimopan)：治疗术后肠梗阻，葛兰素史克公司，5月份批准
Rotarix(轮状病毒活疫苗，口服)治疗儿童G1,G3,G4,G9引起的轮状病毒胃肠炎，葛兰素史克，4月份批准
Tysabri（那他珠单抗）：治疗中重度局限性肠炎，Biogen IDEC公司，1月份批准

血液科
Nplate(romiplostim)：治疗慢性原发性血小板减少性紫癜，安进公司，8月份批准

免疫/传染性疾病
Aptivus（替拉那韦）：治疗艾滋病，Boehringer Ingelheim公司，6月份批准
Cinryze（C1抑制因子，人）：治疗成人和青少年遗传性水肿，Lev制药公司，10月份批准
Intelence (etravirine)：治疗艾滋病，Tibotec公司，1月份批准
Moxatag (阿莫西林)：治疗成年人和儿童化脓性链球菌感染的咽炎和扁桃体炎，MiddleBrooke公司，1月份批准
Viread (替诺褔韦)：治疗乙肝，Gilead公司，9月份批准

骨骼肌：
Orencia (abatacept)：治疗青少年原发性关节炎，百时美施贵宝公司，4月份批准
肾脏/泌尿系统：
Toviaz (fesoterodine fumarate)：治疗膀胱过动症，辉瑞公司，10月份批准

神经病学
Banzel（卢非酰胺）：治疗成人和儿童癫痫发作相关Lennox-Gastaut综合征，卫材药业，4月份批准
Durezol（二氟泼尼酯）：治疗眼科手术后的炎症和疼痛，Sirion Therapeutics公司6月份批准
Stavzor（丙戊酸缓释胶囊）：治疗双相性情感障碍的躁狂发作和偏头痛，Banner 制药公司，7月份批准
Vimpat (lacosamide)：治疗成人局部性癫痫发作，许瓦兹制药有限公司，10月份批准
Xenazine(丁苯那嗪)：治疗亨廷顿舞蹈病，Prestwick 制药公司，8月份批准

妇产科：无批准

肿瘤
Sancuso(格拉司琼):治疗化疗引起的恶心呕吐，ProStrakan公司，9月份批准
Treanda（盐酸苯达莫司汀）：治疗慢性淋巴细胞性白血病和复发难治性B细胞非何杰金氏淋巴瘤，美国塞法隆制药公司，10月份批准

眼科：
Akten（盐酸利多卡因）：眼科手术用麻醉，Akorn公司，10月份批准

耳鼻喉科
Moxatag (阿莫西林)：治疗成年人和儿童化脓性链球菌感染的咽炎和扁桃体炎，MiddleBrooke公司，1月份批准
Patanase（盐酸奥洛他定）：治疗季节性反应性鼻炎，爱尔康公司，4月份批准

小儿科/新生儿：
Accretropin（生长激素原rDNA）：治疗小儿生长迟缓， Cangene Corp，1月份批准
Alvesco (环索奈德)：治疗成人和青少年哮喘的预防性治疗。，奈科明公司，1月份批准
Aptivus（替拉那韦）：治疗艾滋病，Boehringer Ingelheim公司，6月份批准
Banzel（卢非酰胺）：治疗成人和儿童癫痫发作相关Lennox-Gastaut综合征，卫材药业，4月份批准
Cinryze（C1抑制因子，人）：治疗成人和青少年遗传性水肿，Lev制药公司，10月份批准
Moxatag (阿莫西林)：治疗成年人和儿童化脓性链球菌感染的咽炎和扁桃体炎，MiddleBrooke公司，1月份批准
Orencia (abatacept)：治疗青少年原发性关节炎，百时美施贵宝公司，4月份批准
Patanase（盐酸奥洛他定）：治疗季节性反应性鼻炎，爱尔康公司，4月份批准
Rotarix(轮状病毒活疫苗，口服)：治疗儿童G1,G3,G4,G9引起的轮状病毒胃肠炎，葛兰素史克，4月份批准

药理/毒理
Akten（盐酸利多卡因）：眼科手术用麻醉，Akorn公司，10月份批准
Sancuso(格拉司琼):治疗化疗引起的恶心呕吐，ProStrakan公司，9月份批准

精神病学/心理学
Aplenzin（氢溴酸安非他酮）：治疗严重抑郁性障碍，Biovail Labs，4月份批准
Stavzor（丙戊酸缓释胶囊）：治疗双相性情感障碍的躁狂发作和偏头痛，Banner 制药公司，7月份批准

呼吸系统疾病
Alvesco (环索奈德)：治疗成人和青少年哮喘的预防性治疗。，奈科明公司，1月份批准
Patanase（盐酸奥洛他定）：治疗季节性反应性鼻炎，爱尔康公司，4月份批准

风湿病
Orencia (abatacept)：治疗青少年原发性关节炎，百时美施贵宝公司，4月份批准

创伤/急救药

[ Last edited by 桃花源记 on 2008-12-23 at 18:21 ]

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