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Epclusa FDA Approval History

Last updated by Judith Stewart, BPharm on April 6, 2020.

FDA Approved: Yes (First approved June 28, 2016)
Brand name: Epclusa
Generic name: sofosbuvir and velpatasvir
Dosage form: Tablets and Oral Pellets
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 Timeline for Epclusa

DateArticle
Jun 10, 2021Approval  U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C
Mar 19, 2020Approval  FDA Approves Epclusa (sofosbuvir/velpatasvir) for Children Ages 6 and Older or Weighing at Least 17 kg with Chronic Hepatitis C Infection
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

Further information

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