2018年美国FDA批准上市的新药简介

Overviews of the New Drug in 2018 Approved by U.S.FDA

2018年美国食品药品监督管理局(FDA)批准上市新药59个,其中化学小分子42个、生物制品17个。本文根据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 59 new drugs into the market in 2018, including 42 chemical small molecules and 17 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.