U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis

Andrea Meyerhoff

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)42-48
Number of pages7
JournalClinical Infectious Diseases
Volume28
Issue number1
StatePublished - 1999
Externally publishedYes

Fingerprint

Drug Approval
Visceral Leishmaniasis
Food
United States Food and Drug Administration
Infection
Pharmaceutical Preparations
Clinical Trials
liposomal amphotericin B

ASJC Scopus subject areas

  • Immunology

Cite this

U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis. / Meyerhoff, Andrea.

In: Clinical Infectious Diseases, Vol. 28, No. 1, 1999, p. 42-48.

Research output: Contribution to journalArticle

@article{be9b4ddf69334bbaa88dae37f53e2f44,
title = "U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis",
abstract = "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.",
author = "Andrea Meyerhoff",
year = "1999",
language = "English (US)",
volume = "28",
pages = "42--48",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "1",

}

TY - JOUR

T1 - U.S. Food and Drug Administration approval of AmBisome (liposomal amphotericin B) for treatment of visceral leishmaniasis

AU - Meyerhoff, Andrea

PY - 1999

Y1 - 1999

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0032991693&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0032991693&partnerID=8YFLogxK

M3 - Article

C2 - 10028069

AN - SCOPUS:0032991693

VL - 28

SP - 42

EP - 48

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 1

ER -