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BRISTOL ZERIT CONFLICTING ISSUES OF DOSING AND PATIENT POPULATION

Executive Summary

BRISTOL ZERIT CONFLICTING ISSUES OF DOSING AND PATIENT POPULATION leave FDA's Antiviral Drugs Advisory Committee with no recommendation on the drug at its May 20 review of the NDAs (20- 412, 20-413) for Bristol-Myers Squibb's Zerit (stavudine, d4T). The committee agreed that Bristol's studies indicated a dosage -- 40 mg b.i.d. -- that might be dangerously high for the target population of "adults with advanced HIV infection who are intolerant to approved therapies with proven clinical benefit."
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PS024494

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