Sovaldi FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
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
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.