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Harvoni Approval History

  • FDA approved: Yes (First approved October 10th, 2014)
  • Brand name: Harvoni
  • Generic name: ledipasvir and sofosbuvir
  • Dosage form: Tablets
  • Company: Gilead Sciences, Inc.
  • Treatment for: Hepatitis C

Harvoni (ledipasvir and sofosbuvir) is a once-daily NS5A inhibitor and nucleotide analog polymerase inhibitor fixed-dose combination for the treatment of chronic hepatitis C virus (HCV) genotype 1, 4, 5 or 6 infection.

Development History and FDA Approval Process for Harvoni

Apr  7, 2017Approval FDA Approves Harvoni (ledipasvir and sofosbuvir) for Chronic Hepatitis C Infection in Pediatric Patients 12 Years and Older
Feb 16, 2016Approval FDA Approves Two Supplemental Indications for Harvoni in Chronic Hepatitis C Patients With Advanced Liver Disease
Nov 12, 2015Approval FDA Approves New Indications for Harvoni to Include Patients with Genotypes 4, 5 and 6 HCV and Patients Co-Infected with HIV
Oct 10, 2014Approval FDA Approves Harvoni (ledipasvir and sofosbuvir) for Hepatitis C
Apr  7, 2014Gilead Announces FDA Priority Review Designation for Ledipasvir/Sofosbuvir Fixed-Dose Combination
Feb 10, 2014Gilead Files for U.S. Approval of Ledipasvir/Sofosbuvir Fixed-Dose Combination Tablet for Genotype 1 Hepatitis C

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