2013年度FDA批准的创新性药物简析  

Brief analysis on new drugs approved by FDA in 2013

作　　者：刘巍[1] 汤立达[1] 

机构地区：[1]天津药物研究院天津市新药设计与发现重点实验室,天津300193

出　　处：《现代药物与临床》2014年第5期564-566,共3页Drugs & Clinic

摘　　要：美国食品药品监督管理局(FDA)于2013年度共批准27个新药,其中小分子药物25个,生物制品2个,涉及抗肿瘤、代谢和内分泌系统、抗病毒、精神神经系统、呼吸系统、伴随诊断试剂,以及医学影像产品等治疗和应用领域。与2012年批准的39个新药相比,虽然在产品数量上有所下降,但这些药物却具备广阔的商业前景。简要介绍其中的重点品种,并就新药研发的现状与趋势进行分析。The US Food and Drug Administration （FDA） approved 27 new drugs in 2013. There were 25 small molecules and 2 biologics in 2013. The current focus for drug R ＆ D were on antineoplastic drugs, metabolic and endocrinological therapies, antivirals, neuropsychiatric drugs, chronic pulmonary disease treatments, companion diagnostic reagents, and medical imaging products. Although the number of approvals in 2013 was down from 2012 with 39 approvals, the newcomers were set to achieve powerful earning potential. The profile of some exciting products and the trends of drug R ＆ D were provided.

关 键 词：新分子实体 突破性治疗资格药物 孤儿药 

分 类 号：R926[医药卫生—药学]