2017年美国FDA批准上市的抗感染新药介绍与述评

Introduction and commentary of 2017 new anti-infectives approved by the United States FDA

2017年美国食品药品监督管理局(FDA)批准上市新药46个,其中有抗菌药物4个,抗病毒药物3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,简要介绍德拉沙星(delafloxacin)、复方美罗培南(meropenem)、塞克硝唑(secnidazole)、奥泽米星(ozenoxacin)、复方三联抗丙型肝炎制剂(vosevi)、复方抗丙型肝炎制剂(mavyret)和莱特莫韦(letermovir)的药物的概况、合成技术路线、适应症、作用机制、剂型规格、不良反应和合成路线等相关情况。严格来说,塞克硝唑(secnidazole)是一仿制药物,在欧洲已经上市近30年,在中国上市也有10年以上。

In 2017, the US-FDA approved forty-six new drugs listed, including four antibacterial drugs and three antiviral drugs. This article is based on the FDA approved new drug specification and related literatures and patents, a brief description of delafloxacin, compound meropenem, secnidazole, ozenoxacin, and three anti-HCV drugs, vosevi, mavyret and letermovir, including research overview, routes of synthesis, indications, mechanism of action, dosage form specifications, and adverse reactions. Strictly speaking, secnidazole is a generic drug that has been listed for nearly thirty years in Europe and more than ten years in China.