Hussar D A
Philadelphia College of Pharmacy and Science, USA.
Pa Med. 1996 Apr;99(4):43-6.
In 1995, the Food and Drug Administration (FDA) approved 28 new molecular entities (NMEs), 26 of which are for therapeutic use and two of which are diagnostic agents. Fourteen of the NMEs for therapeutic use were both approved and marketed in the United States in 1995. In addition, eight other NMEs and a biological agent for therapeutic use that the FDA approved before 1995 (most in late 1994) were marketed during the year. Thus, a total of 23 therapeutic agents reached the U.S. market for the first time in 1995. Many of the 12 therapeutic agents approved in 1995, but not marketed before the end of the year, were available in early 1996. This review considers the drugs' most important properties and compares them with other available agents with similar properties. This discussion is not intended to be all inclusive; when additional information is needed, more comprehensive references and the product literature should be consulted.
1995年，美国食品药品监督管理局（FDA）批准了28种新分子实体（NMEs），其中26种用于治疗，2种为诊断剂。1995年，14种用于治疗的新分子实体在美国获得批准并上市。此外，FDA在1995年之前（大多在1994年末）批准的其他8种新分子实体和1种用于治疗的生物制剂也在该年上市。因此，1995年共有23种治疗剂首次进入美国市场。1995年批准但在年底前未上市的12种治疗剂中的许多在1996年初即可获得。本综述考虑了这些药物的最重要特性，并将它们与其他具有相似特性的可用药物进行比较。本讨论并非旨在涵盖所有内容；如需更多信息，应查阅更全面的参考文献和产品说明书。
