2015年下半年美国FDA批准药物简介

摘要

2015年下半年美国FDA首次批准上市含新分子实体单药或复方20个，生物制品许可申请15个，共计35个，创历史批准数量最多。本文根据FDA批准的处方资料，简要介绍新药概况、作用机制、黑框警告、适应证、剂量和用法、禁忌证、不良反应、药物相互作用及特殊人群中使用等。并讨论了2015年下半年在药物开发、研究和审评中的首次和重要事件。%In the second half year of 2015,the U.S. Food and Drug Administration(FDA)approved 20 new molecular enti⁃ties single or compounds and 15 biologics license applications,a total of 35 which record number of approved innovative drugs. Ac⁃cording to the prescription information for professionals,this article briefly describes the description,mechanism of action and clinical studies,the box warning,indications and usage,dosage and administration,dosage form and strength,contraindications,warning and precautions,adverse reactions,drug interaction and use in special population of these new drugs. In addition,the first and criti⁃cal events in the history of new drug development and reaserch are emphasized.