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Epclusa Approval History

  • FDA approved: Yes (First approved June 28th, 2016)
  • Brand name: Epclusa
  • Generic name: sofosbuvir and velpatasvir
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: Hepatitis C

Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Development History and FDA Approval Process for Epclusa

DateArticle
Aug  1, 2017Approval FDA Approves Expanded Labeling for Epclusa (sofosbuvir/velpatasvir) for the Treatment of Chronic Hepatitis C in Patients Co-Infected with HIV
Jun 28, 2016Approval FDA Approves Epclusa (sofosbuvir and velpatasvir) for Treatment of all Major Forms of Chronic Hepatitis C Virus Infection
Jan  4, 2016Gilead Announces U.S. FDA Priority Review Designation for Sofosbuvir/Velpatasvir for Treatment of All Genotypes of Chronic Hepatitis C Infection
Oct 28, 2015Gilead Submits NDA to U.S. FDA for Fixed-Dose Combination of Sofosbuvir/Velpatasvir for Treatment of All Six Genotypes of Hepatitis C

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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