Clin Infect Dis. 1999 Jan;28(1):42-8; discussion 49-51.
U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis.
Meyerhoff A1.
Division of Special Pathogens and Immunologic Drug Products, U.S. Food and Drug Administration, Rockville, Maryland 20850, USA.
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.
U.S Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. [Clin Infect Dis. 1999]
10.1086/515085
Amphotericin B/administration & dosage
Amphotericin B/adverse effects
Amphotericin B/therapeutic use*
Antiprotozoal Agents/administration & dosage
Antiprotozoal Agents/adverse effects
Antiprotozoal Agents/therapeutic use*
Drug Approval*
Drug Carriers
Leishmaniasis, Visceral/drug therapy*
United States Food and Drug Administration
Antiprotozoal Agents
liposomal amphotericin B
Leishmaniasis - Genetic Alliance
AMPHOTERICIN B - Hazardous Substances Data Bank