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Vitekta Approval History

  • FDA approved: Yes (First approved September 24th, 2014)
  • Brand name: Vitekta
  • Generic name: elvitegravir
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: HIV Infection

Vitekta (elvitegravir) is an integrase inhibitor for the combination treatment of HIV-1 infection in treatment-experienced adults.

Development History and FDA Approval Process for Vitekta

Sep 25, 2014Approval FDA Approves Vitekta (elvitegravir) for HIV-1 Infection
Apr 21, 2014Gilead Sciences’ New Drug Application for Elvitegravir for HIV Therapy Accepted by U.S. FDA
Apr 29, 2013Gilead Receives Complete Response Letters from U.S. Food and Drug Administration for Elvitegravir and Cobicistat
Jun 27, 2012Gilead Submits New Drug Application to U.S. FDA for HIV Integrase Inhibitor Elvitegravir for Treatment-Experienced Patients

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