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Vemlidy Approval History

  • FDA approved: Yes (First approved November 10th, 2016)
  • Brand name: Vemlidy
  • Generic name: tenofovir alafenamide
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: Hepatitis B

Vemlidy (tenofovir alafenamide) is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.

Development History and FDA Approval Process for Vemlidy

DateArticle
Nov 10, 2016Approval FDA Approves Gilead’s Vemlidy (tenofovir alafenamide) for the Treatment of Chronic Hepatitis B Virus Infection
Jan 12, 2016Gilead Submits New Drug Application to U.S. FDA for Tenofovir Alafenamide (TAF) for the Treatment of Chronic Hepatitis B
Jan  5, 2016Gilead Announces Top-Line Results From Two Phase 3 Studies Evaluating Tenofovir Alafenamide (TAF) for Patients With Chronic Hepatitis B Infection

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