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Zepatier Approval History

  • FDA approved: Yes (First approved January 28th, 2016)
  • Brand name: Zepatier
  • Generic name: elbasvir and grazoprevir
  • Dosage form: Tablets
  • Company: Merck & Co., Inc.
  • 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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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