Skip to main content

Mavyret FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved August 3, 2017)
Brand name: Mavyret
Generic name: glecaprevir and pibrentasvir
Dosage form: Tablets and Oral Pellets
Company: AbbVie Inc.
Treatment for: Hepatitis C

Mavyret (glecaprevir/pibrentasvir) is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of all major genotypes (GT1-6) of chronic hepatitis C.

Development timeline for Mavyret

DateArticle
Sep 27, 2019Approval FDA Approves Mavyret (glecaprevir/pibrentasvir) Treatment Duration of Eight Weeks for Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes
Apr 30, 2019Approval FDA Approves Mavyret (glecaprevir and pibrentasvir) as First Treatment for All Genotypes of Hepatitis C in Pediatric Patients
Aug  3, 2017Approval FDA Approves Mavyret (glecaprevir and pibrentasvir) for Hepatitis C
Feb  2, 2017U.S. FDA Grants Priority Review to AbbVie for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of Chronic Hepatitis C in All Major Genotypes (GT1-6)
Dec 19, 2016AbbVie Submits NDA to FDA for its Investigational Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes of Chronic Hepatitis C

See also

Mavyret (glecaprevir and pibrentasvir) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer