2016年第一季度，美國食品藥品監(jiān)督管理局（FDA）共批準新藥上市申請（NDA）23件和生物制品許可申請（BLA）3件。其中1類新分子實體（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IL-17A單抗抗炎藥ixekizumab，以及FDA批準的第1個治療嚴重肝小靜脈閉塞的藥物去纖苷鈉。主要對批準的1類NME新藥進行綜述，包括其上市簡介、適應癥、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.