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Zepatier 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 History and FDA Approval Process 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
Apr  8, 2015Merck’s Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir Granted FDA Breakthrough Therapy Designations
Nov  9, 2014Interim Data from Proof-of-Concept Study of Merck’s Investigational Hepatitis C Treatment Grazoprevir/Elbasvir Presented

Further information

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