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1999年美国食品药品管理局(FDA)共批准了35个新分子实体,其中33个用于治疗目的,2个用于诊断目的。33个治疗用新分子实体中的20个及1个治疗用新生物药物已于当年在美国上市,另有7个以前被FDA批准的其它药物亦于1999年开始在美国正式应市。即:1999年美国共首次上市了28个新治疗药物,其中14个属当年世界首次上市新药。本文欲依药效分类,就此14个新药作一概要介绍。
In 1999, the U.S. Food and Drug Administration (FDA) approved a total of 35 new molecular entities, of which 33 were for therapeutic purposes and 2 were for diagnostic purposes. Twenty of the 33 therapeutic new molecular entities and one new therapeutic biopharmaceutical have been marketed in the United States during the year, and seven other drugs that were previously approved by the FDA also began to officially enter the United States in 1999. That is, in 1999, the United States listed a total of 28 new therapeutic drugs for the first time, of which 14 were the first new drugs to be listed in the world that year. This article wants to classify according to the efficacy of drugs, this brief introduction of 14 new drugs.