Hussar D A
Philadelphia College of Pharmacy and Science.
Pa Med. 1994 Apr;97(4):12-6.
In 1993, the Food and Drug Administration (FDA) approved 25 new molecular entities (NMEs), 23 of which are for therapeutic use and two are diagnostic agents. Eleven of the NMEs for therapeutic use, as well a new biological agent intended for therapeutic use, were both approved and marketed in the United States in 1993. In addition, 11 other NMEs that the FDA approved before 1993 (most in late 1992) were marketed during the year. Thus, a total of 23 therapeutic agents reached the U.S. market for the first time in 1993, a considerably lower number than the 30 new therapeutic agents marketed in 1992 and the record number 31 new agents marketed in 1991. Many of the 13 therapeutic agents approved in 1993 but not marketed before the end of the year have become available in early 1994. This review of the therapeutic agents first marketed in 1993 considers their most important properties and, when possible, compares them with other available agents with similar properties. Of the 23 new therapeutic agents, 22 are considered in this paper. The one agent not reviewed is flosequinan, which was withdrawn from the market after being available only several months because of a concern about toxicity. This discussion of new drugs focuses on the most important properties of these agents; when additional information is needed, more comprehensive references and the product literature should be consulted.
1993年，美国食品药品监督管理局（FDA）批准了25种新分子实体（NMEs），其中23种用于治疗，2种为诊断试剂。1993年，11种用于治疗的NMEs以及一种用于治疗的新生物制剂在美国获得批准并上市。此外，FDA在1993年之前（大多数在1992年末）批准的其他11种NMEs也在当年上市。因此，1993年共有23种治疗药物首次进入美国市场，这一数字远低于1992年上市的30种新治疗药物以及1991年创纪录的31种新药物。1993年批准但在年底前未上市的13种治疗药物中的许多已于1994年初上市。这篇对1993年首次上市的治疗药物的综述考虑了它们最重要的特性，并在可能的情况下将它们与其他具有相似特性的现有药物进行比较。在这23种新治疗药物中，本文讨论了22种。未被综述的一种药物是氟司喹南，由于对其毒性的担忧，该药物仅上市几个月后就被撤出市场。本文对新药的讨论集中在这些药物的最重要特性上；如需更多信息，应查阅更全面的参考文献和产品说明书。
