2022年美国FDA批准上市的新药简介  

Overviews of the New Drug in 2022 Approved by U.S.FDA

作　　者：毕思举 林快乐[1] 刘玲玲[2] 周伟澄[1] BI Siju;LIN Kuaile;LIU Lingling;ZHOU Weicheng(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 Informational 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》2023年第1期1-18,共18页Chinese Journal of Pharmaceuticals

摘　　要：2022年美国食品药品监督管理局(Food and Drug Administration,FDA)批准上市新药37个,其中化学小分子22个、生物制品15个。该研究根据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.Food and Drug Administration(FDA)approved 37 new drugs into the market in 2022,including 22 chemical small molecules and 15 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 reactions,and one synthetic route of the chemical small molecules,and brief information about 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]