2021年美国FDA批准上市的新药简介  

Overviews of the New Drugs in 2021 Approved by U.S. FDA

作　　者：刘潍源 林快乐[1] 刘玲玲[2] 周伟澄[1] LIU Weiyuan;LIN Kuaile;LIU Lingling;ZHOU Weicheng(Shanghai Key Lab.of Anti-infectives,State Key Lab.of New Drug and Pharmaceutical Process,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203;China National Pharmaceutical Information Center,Shanghai 200040)

机构地区：[1]中国医药工业研究总院上海医药工业研究院,创新药物与制药工艺国家重点实验室,上海市抗感染药物研究重点实验室,上海201203 [2]中国医药工业信息中心,上海200040

出　　处：《中国医药工业杂志》2022年第1期1-27,共27页Chinese Journal of Pharmaceuticals

摘　　要：2021年美国FDA批准上市新药50个,其中化学小分子36个、生物制品14个。现根据FDA批准的新药说明书以及相关文献和专利情况,简要介绍化学小分子药物的概况、适应证、作用机制、剂型规格、不良反应和合成路线等,以及生物制品的相关情况。The U.S. FDA approved 50 new drugs into the market in 2021,including 36 chemical small molecules and 14 biological products.According to the prescription information for professionals and the related literature as well as patent information,this review describes the descriptions,indications,mechanism of action,dosage form and strength,adverse reaction,and one synthetic route of the chemical small molecules,and brief information about the biological products.

关 键 词：美国FDA 新药批准 适应证 合成路线 

分 类 号：R97[医药卫生—药品]