Harvoni® (ledipasvir/sofosbuvir) – Expanded orphan indication, new formulation approval
August 28, 2019 - The FDA approved Gilead’s Harvoni (ledipasvir/sofosbuvir), for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) for Genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; Genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin; Genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin.
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