2013年上半年美国FDA批准药物简介

Overviews and analysis of the U. S. FDA’s new approvals in 2013 first half year

2013年上半年美国食品药品监督管理局(FDA)批准58种新药(包括修改说明书、新剂型和新组方),其中首次批准上市的新分子实体12个、新生物制品5个。本文根据FDA批准药物的处方资料介绍新药的概况、作用机制、临床试验、适应证、剂量和用法、禁忌证、不良反应、黑框警告、药物相互作用及特殊人群中使用要点等,并讨论了批准新药在药物开发、研究和审评使中的首次事件。

In the first half of 2013,the U.S.Food and Drug Administration（FDA） approved 58 new drugs,including 12 new molecular entities and 5 new biological products.According to the prescription information for professionals,this article introduces the description,mechanism of action and clinical studies,and briefly describes indications and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions,the box warning,drug interaction and use in special population of these new drugs.In addition,the ＂ first events＂ in the history of new drug research,development and approval are also discussed.