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

Date	Article
Apr 7, 2017	Approval FDA Approves Sovaldi (sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older
Dec 6, 2013	Approval FDA Approves Sovaldi for Chronic Hepatitis C
Oct 25, 2013	FDA Advisory Committee Supports Approval of Gilead’s Sofosbuvir for Chronic Hepatitis C Infection
Jun 7, 2013	Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir for the Treatment of Hepatitis C
Apr 9, 2013	Gilead Submits New Drug Application to U.S. FDA for Sofosbuvir for the Treatment of Hepatitis C

Further information

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Sovaldi FDA Approval History

Development timeline for Sovaldi

See also

Further information