Treats chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection. NDA 214187, held by Gilead Sciences Inc. Sofosbuvir; Velpatasvir.
As of Nov 14, 2026, NDA 214187 (Epclusa), held by Gilead Sciences Inc, was first approved by FDA on Jun 10, 2021, with 1 approved supplement and 0 published complete response letters.
EPCLUSA is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.
| Apr 27, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 10, 2021 | Original applicationNew dosage form · Priority review | Approved |
| Epclusa150MG/PACKET;37.5MG/PACKET · pellets;oral | Sofosbuvir; Velpatasvir | RxReference drug |
| Epclusa200MG/PACKET;50MG/PACKET · pellets;oral | Sofosbuvir; Velpatasvir | RxReference drug |
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
