Sovaldi Approval History beta

  • FDA approved: Yes (First approved December 6th, 2013)
  • Brand name: Sovaldi
  • Generic name: sofosbuvir
  • Company: Gilead Sciences
  • Treatment for: Hepatitis C

Sovaldi (sofosbuvir) is a once-daily oral nucleotide analogue for the treatment of chronic hepatitis C virus (HCV) infection.

FDA Approval History for Sovaldi

DateArticle
Dec  6, 2013Approval FDA Approves Sovaldi for Chronic Hepatitis C
Oct 25, 2013FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection
Jun  7, 2013Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C
Apr  9, 2013Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C

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