Skip to Content

Sovaldi Approval History

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

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

Development History and FDA Approval Process for Sovaldi

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.