2007-2011年美国FDA批准新药概况

摘要

近5年,随着药品市场集中化程度的提高及竞争的加剧,新药研发速度迟缓,上市新药基本维持在27个左右.2011年全球新药研发再掀高潮,美国FDA批准上市的新药数目创近5年新高,文中按照肿瘤、心血管疾病、感染性疾病、代谢疾病、风湿疾病等几大重点治疗领域,对2007-2011年FDA批准上市的治疗性新药进行介绍.%Nearly five years, along with the enhancement of the pharmaceutical market centralization and drastic competition, the development of new drug is slow, and about 27 new drugs entered the market every year. Global R&D of new drugs seems to recover in 2011 , as the approval of new chemical entities (NCEs) by US FDA expected to hit a new high within this decade. According to the key therapeutic categories such as tumor, cardiovascular diseases, infectious diseases, metabolic diseases and rheumatology, this paper presented the details of the new drug launches and some products at late-stage of development.