Important note: Information in this article was accurate in 2006. The state of the art may have changed since the publication date.
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Food and Drug Administration - March 10, 2006
Richard Klein, Kimberly Struble
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 na ve 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.
The updated label for Viread and Truvada can be viewed at:
Richard Klein, Office of Special Health Issues
Food and Drug Administration
Kimberly Struble, Division of Antiviral Drug Products
Food and Drug Administration
060308
FD060304
SOURCE: Food and Drug Administration (FDA).
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Download PDF of Updated Label