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Medical Letter on the CDC & FDA

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HIV/AIDS Treatment



U.S. FDA approves Truvada as part of HIV combination therapy



September 5th, 2004

Gilead Sciences (GILD) announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Truvada (emtricitabine and tenofovir disoproxil fumarate) a fixed-dose combination of the company's anti-HIV medications Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate).

Truvada combines 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate in one tablet, taken once a day in combination with other antiretroviral agents.

Gilead also announced that it has received clearance from the FDA for an alternate trade dress for Truvada for use in the developing world. The company plans to include Truvada in the...


Source: Medical Letter on the CDC & FDA (2004-09-05)

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