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Odefsey Approval History

  • FDA approved: Yes (First approved March 1st, 2016)
  • Brand name: Odefsey
  • Generic name: emtricitabine, rilpivirine and tenofovir alafenamide
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: HIV Infection

Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) is a fixed-dose combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and rilpivirine (RPV), a non-nucleoside reverse transcriptase inhibitor (NNRTI), indicated as a complete regimen for the treatment of HIV-1 infection.

Development History and FDA Approval Process for Odefsey

DateArticle
Mar  1, 2016Approval FDA Approves Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide) for the Treatment of HIV-1 Infection
Jul  1, 2015Gilead Submits NDA for Single Tablet Regimen for HIV Containing Rilpivirine, Emtricitabine and Tenofovir Alafenamide

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