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桃花源记铁杆木虫 (正式写手)
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[交流]
2008年FDA 批准新药名单（截止11月底）
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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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