2012年美國(guó)食品藥品監(jiān)督管理局（FDA）共批準(zhǔn)39個(gè)新藥。在2012年FDA批準(zhǔn)上市的新藥中，有20個(gè)為首創(chuàng)一類新藥，其中包括首個(gè)直接針對(duì)病因治療囊性纖維化的新型藥物依伐卡托；40年來首次獲準(zhǔn)用于多藥耐藥性肺結(jié)核治療的貝達(dá)喹啉；第1個(gè)基于FDA的動(dòng)物有效性研究原則獲準(zhǔn)上市的新藥瑞西巴庫(kù)單抗；第1個(gè)用于艾滋病相關(guān)腹瀉，也是第1個(gè)獲準(zhǔn)上市的口服植物藥可非雷默。簡(jiǎn)要介紹其中的重點(diǎn)品種，并就新藥研發(fā)的現(xiàn)狀與趨勢(shì)進(jìn)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.