摘要
目的:对2014年美国FDA批准的新药进行分析,供医药界和相关管理部门参考。方法:查阅Drugs@FDA数据库,收集2014年FDA批准的新药信息,进行统计分析。结果与结论:2014年FDA共批准41个新药,是自1997年以来的最高数量,其中新药申请(新分子实体)30个、生物制品许可申请11个。批准的新药中获得优先审查、突破性治疗、加速审批和快速通道资格的分别为25个、9个、8个和17个(有的新药获得一种以上优先资格),认定孤儿药的为17个。批准新药的治疗领域以抗微生物药(皮肤及皮肤组织感染、基因1型丙肝感染和趾甲真菌感染等)、抗肿瘤药(淋巴瘤、黑色素瘤等)和代谢系统用药(2型糖尿病等)为主,剂型以注射剂、片剂和胶囊剂为主。
Objective： To make an analysis on novel drugs approved by FDA in 2014 so as to provide references for the medicine field and the related management departments. Methods： The information of the novel drugs which were approved by the Food and Drug Administration（FDA） in 2014 was collected and analyzed by retrieving the Drugs@FDA databases. Results and Conclusion： FDA approved a total of 41 novel drugs in 2014, including 30 new drug applications（new molecular entity） and 11 biologics license applications. The number of approval in 2014 was the highest since 1997. Among the approved drugs, 25, 9, 8, 17 and 17 novel drugs gained priority review, breakthrough therapy designation, accelerated approval, fast track（some gained more than one priority） and orphan product designation respectively. The main therapeutic drugs were antibacterial drugs（for skin and skin structure infections, hepatitis C virus genotype 1 infection, toe-nail fungal infection, etc.）, antitumor drugs（for lymphomas, melanomas, etc.）, and drugs for metabolism system（for type 2 diabetes, etc.）. The main dosage forms of the novel drugs were injections, tablets and capsules.
出处
《中国药事》
CAS
2015年第6期618-622,共5页
Chinese Pharmaceutical Affairs
