2016年第一季度，美國(guó)食品藥品監(jiān)督管理局（FDA）共批準(zhǔn)新藥上市申請(qǐng)（NDA）23件和生物制品許可申請(qǐng)（BLA）3件。其中1類(lèi)新分子實(shí)體（NME）藥物僅有3種，分別為治療癲癇新藥布瓦西坦、繼secukinumab之后上市的第2個(gè)IL-17A單抗抗炎藥ixekizumab，以及FDA批準(zhǔn)的第1個(gè)治療嚴(yán)重肝小靜脈閉塞的藥物去纖苷鈉。主要對(duì)批準(zhǔn)的1類(lèi)NME新藥進(jìn)行綜述，包括其上市簡(jiǎn)介、適應(yīng)癥、劑量用法、臨床研究等。

Totally 23 drugs of NDA (New Drug Application) and three biological products of BLA (Biological License Applications) were approved by FDA in the first quarter of 2016, including three drugs of NME (new molecular entity). The three NMEs are brivaracetam treating epilepsy, ixekizumab, the second IL-17A anti-inflammatory agent of monoclonal antibody since secukinumab, and defibrotide sodium, the first drug approved by FDA for treating adult and pediatric patients with hepatic veno occlusive disease. This paper reviews all the NMEs, including their marketing introductions, indications, dosage and usage, and clinical researches, etc.