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U.S. Department of Health and Human Services

For Consumers

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Traditional approval of Viread and Truvada

On March 8, 2006, FDA granted traditional approval to two tenofovir DF containing products manufactured by Gilead Sciences, VIREAD (tenofovir disoproxil fumarate) and TRUVADA (fixed dose combination of tenofovir DF and emtricitabine). Both products are indicated for the treatment of HIV in combination with other antiretroviral drugs.

VIREAD and TRUVADA had received accelerated approval on Oct. 26, 2001 and August 2, 2004, respectively. Traditional approval is supported by previously submitted studies and the recently submitted Study 934, which compared the antiviral activity of tenofovir DF, emtricitabine, and efavirenz to zidovudine, lamivudine and efavirenz in treatment naïve HIV-infected individuals receiving these regimens through 48 weeks.

The results of Study 934 are included in the updated package inserts of VIREAD and TRUVADA. Highlights of the label changes are summarized in the attached pdf file.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration