Treats chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection. NDA 208341, held by Gilead Sciences Inc. Sofosbuvir; Velpatasvir.
As of Nov 13, 2026, NDA 208341 (Epclusa), held by Gilead Sciences Inc, was first approved by FDA on Jun 28, 2016, with 11 approved supplements 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2022 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jun 10, 2021 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Jul 14, 2020 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2020 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Nov 15, 2019 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Aug 1, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jun 28, 2016 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Epclusa400MG;100MG · tablet;oral | Sofosbuvir; Velpatasvir | RxReference drug |
| Epclusa200MG;50MG · tablet;oral | Sofosbuvir; Velpatasvir | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 14, 2022 | Supplement 20Manufacturing | Approved | |
| Apr 27, 2022 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jun 10, 2021 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Jul 14, 2020 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Mar 19, 2020 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Nov 15, 2019 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2019 | Supplement 13Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 9Labeling · Standard review | Approved | |
| Aug 31, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Aug 1, 2017 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Feb 14, 2017 | Supplement 2Labeling | Approved | |
| Jun 28, 2016 | Original applicationNew molecular entity, new combination · 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
