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Truvada Approval History

FDA Approved: Yes (First approved August 2, 2004)
Brand name: Truvada
Generic name: emtricitabine and tenofovir
Dosage form: Tablets
Company: Gilead Sciences, Inc.
Treatment for: HIV Infection, Pre-Exposure Prophylaxis

Truvada (emtricitabine and tenofovir disoproxil fumarate) is a combination of nucleoside analog HIV-1 reverse transcriptase inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in people at high risk.

Development History and FDA Approval Process for Truvada

DateArticle
May  9, 2019Gilead Sciences to Provide Free Truvada for PrEPĀ® to Support U.S. Initiative to End the HIV Epidemic
May 15, 2018Approval FDA Approves Expanded Indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for Reducing the Risk of Acquiring HIV-1 in Adolescents
Jul 16, 2012Approval FDA Approves Truvada for Reducing the Risk of Sexually Acquired HIV Infection
Aug  2, 2004Approval Truvada Gilead Sciences, Inc. - Treatment for HIV Infection
May 17, 2004U.S. FDA Grants Priority Review to Gilead's Fixed Dose Co-Formulation of Viread and Emtriva for HIV
Mar 15, 2004Gilead Submits Applications to U.S. and European Regulatory Authorities for Fixed Dose Co-Formulation of Viread and Emtriva

Further information

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