Journal Article

U.S. Food and Drug Administration Approval of AmBisome (Liposomal Amphotericin B) for Treatment of Visceral Leishmaniasis

Andrea Meyerhoff

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 1, pages 42-48
Published in print January 1999 | ISSN: 1058-4838
Published online January 1999 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/515085
U.S. Food and Drug Administration Approval of AmBisome (Liposomal Amphotericin B) for Treatment of Visceral Leishmaniasis

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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.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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