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Epclusa Approval History

FDA Approved: Yes (First approved June 28, 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

Further information

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