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Harvoni FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

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

Harvoni (ledipasvir and sofosbuvir) is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, indicated for the treatment of chronic hepatitis C virus (HCV) in adults and pediatric patients 3 years of age and older:

  • genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
  • genotype 1 infection with decompensated cirrhosis, in combination with ribavirin
  • genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.

Development timeline 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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.