Harvoni Approval History
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 History and FDA Approval Process for Harvoni
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