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Article
September 18, 1987

Approval of Zidovudine (AZT) for Acquired Immunodeficiency SyndromeA Challenge to the Medical and Pharmaceutical Communities

Author Affiliations

From the Departments of Pediatrics and Surgery, Uniformed Services University of Health Sciences, Bethesda, Md; and the Anti-Infective Drugs Advisory Committee to the Food and Drug Administration, Rockville, Md.

From the Departments of Pediatrics and Surgery, Uniformed Services University of Health Sciences, Bethesda, Md; and the Anti-Infective Drugs Advisory Committee to the Food and Drug Administration, Rockville, Md.

JAMA. 1987;258(11):1517. doi:10.1001/jama.1987.03400110099035
Abstract

THE ANTI-INFECTIVE Advisory Committee to the Food and Drug Administration (FDA) recently recommended the approval of zidovudine (azidothymidine [AZT]) for use as a treatment of selected patients with acquired immunodeficiency syndrome (AIDS), but only for those with advanced illness characterized by Pneumocystis carinii pneumonia and depressed immunity and for symptomatic cases of AIDS-related complex (ARC). It did not, however, recommend approval of zidovudine for treatment of pre-AIDS or nonadvanced AIDS cases with other opportunistic infections. Within two months of that recommendation, the FDA released the drug for use for the above indications.

The committee, which I chaired, was made up of 11 medical experts in infectious diseases and other disciplines; it was asked to review data from one placebo-controlled clinical trial of patients with AIDS who had recovered from their first episode of P carinii pneumonia before enrollment and patients with ARC who had multiple clinical symptoms, such as oral

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