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U.S. Department of Health and Human Services

Drugs

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Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate (marketed as Truvada) Information

On July 16, 2012, the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually-acquired HIV infection in adults at high risk.

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Regulatory History and Labeling from Drugs@FDA

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