Treats acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection…. NDA 215110, held by Abbvie. Glecaprevir; Pibrentasvir.
As of Nov 14, 2026, NDA 215110 (Mavyret), held by Abbvie, was first approved by FDA on Jun 10, 2021, with 3 approved supplements and 0 published complete response letters.
MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with acute or chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
| Jun 10, 2025 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Jun 10, 2021 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mavyret50MG/PACKET;20MG/PACKET · pellets;oral | Glecaprevir; Pibrentasvir | RxReference drug |
| Jun 10, 2025 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Oct 25, 2023 | Supplement 3Labeling · Standard review | Approved | |
| Sep 28, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Jun 10, 2021 | 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
