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FDA's Antiviral Drugs Advisory Committee

Executive Summary

On July 20, will discuss data supporting supplemental NDAs for Burroughs Wellcome's Retrovir (zidovudine, AZT) for protection against maternal-fetal transmission of HIV. The committee will review data from SNDAs 19-655/023, 19-910/011 and 19-951/003 at Parklawn, conference rooms G, H, I & J. Open committee discussion begins at 8 a.m.; the open public hearing begins at 11 a.m. The ACTG 076 study of AZT for use in preventing maternal-fetal transmission of HIV found that when both mother and infant received AZT, the rate of transmission was reduced to 8.3% as compared to the placebo group transmission rate of 25.5% ("The Pink Sheet" Feb. 28, T&G-6)

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