Roche's Invirase, Glaxo's 3TC and Bristol's Zerit slated for FDA committee review Nov. 6-8.
Executive Summary
INVIRASE, 3TC, ZERIT AIDS THERAPIES WILL RECEIVE FDA REVIEW by the Antiviral Drugs Advisory Committee Nov. 6-8. The committee will discuss approvability recommendations for Roche's proteinase inhibitor Invirase (saquinavir) and Glaxo Wellcome/Biochem Pharma's nucleoside analog 3TC (lamivudine), and discuss validation of clinical endpoints for Bristol-Myers Squibb's Zerit (stavudine, d4T).