Skip to main content

Zepatier FDA Approval History

FDA Approved: Yes (First approved January 28, 2016)
Brand name: Zepatier
Generic name: elbasvir and grazoprevir
Dosage form: Tablets
Company: Merck
Treatment for: Hepatitis C

Zepatier (elbasvir and grazoprevir) is a once-daily, single tablet, NS5A replication complex inhibitor and NS3/4A protease inhibitor combination for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections.

Development timeline for Zepatier

DateArticle
Jan 28, 2016Approval FDA Approves Zepatier (elbasvir and grazoprevir) for Chronic Hepatitis C Genotypes 1 and 4
Jul 28, 2015Merck Announces FDA Acceptance of NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4 and 6 Infection
May 28, 2015Merck Submits NDA for Grazoprevir/Elbasvir for Chronic Hepatitis C Genotypes 1, 4, and 6 Infection

Further information

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