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

Andrea Meyerhoff | Zendy

Open Access

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

Author(s) -

Andrea Meyerhoff

Publication year - 1999

Publication title -

clinical infectious diseases

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 3.44

H-Index - 336

eISSN - 1537-6591

pISSN - 1058-4838

DOI - 10.1086/515085

Subject(s) - medicine , visceral leishmaniasis , food and drug administration , drug , amphotericin b , clinical trial , leishmaniasis , pharmacology , intensive care medicine , antifungal , immunology , dermatology

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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