Meyerhoff A
Division of Special Pathogens and Immunologic Drug Products, U.S. Food and Drug Administration, Rockville, Maryland 20850, USA.
Clin Infect Dis. 1999 Jan;28(1):42-8; discussion 49-51. doi: 10.1086/515085.
In August 1997, AmBisome (liposomal amphotericin B, Nexstar, San Dimas, CA) was the first drug approved for the treatment of visceral leishmaniasis by the U.S. Food and Drug Administration. The growing recognition of emerging and reemerging infections warrants that safe and effective agents to treat such infections be readily available in the United States. The following discussion of the data submitted in support of the New Drug Application for AmBisome for the treatment of visceral leishmaniasis shows the breadth of data from clinical trials that can be appropriate to support approval for drugs to treat tropical diseases.
1997年8月，安必素（两性霉素B脂质体，Nexstar公司，加利福尼亚州圣迪马斯）成为美国食品药品监督管理局批准用于治疗内脏利什曼病的首款药物。对新出现和再度出现的感染的认识不断提高，这就要求美国要有安全有效的药物来治疗此类感染。以下对为支持安必素治疗内脏利什曼病的新药申请而提交的数据的讨论，显示了临床试验中可用于支持批准治疗热带疾病药物的广泛数据。
