Treats chronic hepatitis C virus (HCV). NDA 212477, held by Gilead Sciences Inc. Ledipasvir; Sofosbuvir.
As of Nov 13, 2026, NDA 212477 (Harvoni), held by Gilead Sciences Inc, was first approved by FDA on Aug 28, 2019, with 5 approved supplements and 0 published complete response letters.
HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV): genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV) in adults and p…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 28, 2019 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Harvoni33.75MG/PACKET;150MG/PACKET · pellets;oral | Ledipasvir; Sofosbuvir | RxReference drug |
| Harvoni45MG/PACKET;200MG/PACKET · pellets;oral | Ledipasvir; Sofosbuvir | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2024 | Supplement 6Labeling · Standard review | Approved | |
| Mar 5, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Dec 4, 2019 | Supplement 4Labeling · Standard review | Approved | |
| Nov 15, 2019 | Supplement 2Efficacy (new indication or use) · 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
