Treats chronic hepatitis C virus (HCV) genotype 1 or 4 infection. NDA 208261, held by Msd Sub Merck. Elbasvir; Grazoprevir.
As of Nov 13, 2026, NDA 208261 (Zepatier), held by Msd Sub Merck, was first approved by FDA on Jan 28, 2016, with 6 approved supplements and 0 published complete response letters.
ZEPATIER is indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations. ZEPATIER is a fixed-dose combination product containing elbasvir, a hepatitis C virus (HCV) NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor, and is indicated for treatment of chronic HCV genotype 1 or 4 infection in adult and pediatric patients 12 years of age and older or weighing at least 30 kg. ZEPATIER is indicated for use with ribavirin in certain patient populations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jan 28, 2016 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zepatier50MG;100MG · tablet;oral | Elbasvir; Grazoprevir | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 9, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Dec 11, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Jun 28, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Feb 14, 2017 | Supplement 2Labeling | Approved | |
| Jan 10, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Jan 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
