2012年美国食品药品监督管理局（FDA）共批准39个新药。在2012年FDA批准上市的新药中，有20个为首创一类新药，其中包括首个直接针对病因治疗囊性纤维化的新型药物依伐卡托；40年来首次获准用于多药耐药性肺结核治疗的贝达喹啉；第1个基于FDA的动物有效性研究原则获准上市的新药瑞西巴库单抗；第1个用于艾滋病相关腹泻，也是第1个获准上市的口服植物药可非雷默。简要介绍其中的重点品种，并就新药研发的现状与趋势进行分析。

The US Food and Drug Administration (FDA) approved 39 new drugs in 2012. There were 20 first-in-class agents in the 2012 FDA approvals. Particularly noteworthy first-in-class products include ivacaftor, the first cystic fibrosis drug to target the gene defect underlying the disease: bedaquiline, the first new drug to treat multi-drug-resistant pulmonary tuberculosis in the last 40 years; raxibacumab, the first product approved under the FDA’s animal efficacy rule; crofelemer, the first drug approved for HIV-associated diarrhea, and also the first oral botanical drug product. The profile of some exciting products and the trends of drug R&D are provided.