U.S. FDA Grants Traditional Approval For Gilead Sciences (Foster City, CA)'s Once-Daily HIV Medications Truvada(R) And Viread(R)

FOSTER CITY, Calif.--(BUSINESS WIRE)--March 8, 2006--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted traditional approval status to its once-daily antiretroviral Viread(R) (tenofovir disoproxil fumarate) and its fixed-dose product Truvada(R) (emtricitabine and tenofovir disoproxil fumarate), which combines the company’s two antiretrovirals Emtriva(R) (emtricitabine) and Viread in a single daily tablet. Traditional approval status was granted following FDA review of 48-week data from Study 934, the second confirmatory pivotal study for Viread. The FDA previously granted accelerated approval for Viread and Truvada in October 2001 and August 2004, respectively.

MORE ON THIS TOPIC