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Truvada Approval History

  • FDA approved: Yes (First approved August 2nd, 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

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

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