Treats chronic hepatitis C virus (HCV) infection as a component of a combination…. NDA 212480, held by Gilead Sciences Inc. Sofosbuvir.
As of Nov 13, 2026, NDA 212480 (Sovaldi), held by Gilead Sciences Inc, was first approved by FDA on Aug 28, 2019, with 4 approved supplements and 0 published complete response letters.
SOVALDI 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2019 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sovaldi150MG/PACKET · pellets;oral | Sofosbuvir | RxReference drug |
| Sovaldi200MG/PACKET · pellets;oral | Sofosbuvir | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Mar 5, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Dec 4, 2019 | Supplement 3Labeling · Standard review | Approved | |
| Sep 19, 2019 | Supplement 1Labeling · Standard review | Approved | |
| Aug 28, 2019 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
