Skip to Content

Sovaldi FDA Approval History

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

Sovaldi (sofosbuvir) is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of:

  • adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen.
  • pediatric patients 3 years of age and older with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis in combination with ribavirin.

Development Timeline for Sovaldi

DateArticle
Apr  7, 2017ApprovalFDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older
Dec  6, 2013ApprovalFDA 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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.