In Brief: Glaxo Wellcome's 3TC
Executive Summary
Glaxo Wellcome's 3TC: Tradename is Epivir (lamivudine). The nucleoside analog's NDAs (20-564 for tablets and 20-596 for oral solution) for treatment of HIV infection are scheduled for a Nov. 6 review by FDA's Antiviral Drugs Advisory Committee ("The Pink Sheet" Oct. 2, T&G-1). On Nov. 7, the committee will review Roche's Invirase (saquinivir) NDA (20-628) for HIV infection. Confirmatory trials of Bristol-Myers Squibb's Zerit (stavudine) will be reviewed on Nov. 8. The meeting will begin at 8:30 a.m. Nov. 6-7. On Nov. 8, the meeting will be open from 8 a.m. to 12:30 p.m., with the afternoon session closed. The meeting will be held at the Quality Hotel, 8727 Colesville Rd. in Silver Spring, Md...