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# FDA OKs 2 Gilead NDA Supplements for Hepatitis C
- URL: https://www.fdaweb.com/fda-oks-2-gilead-nda-supplements-for-hepatitis-c/
- Published: 2017-04-07T12:00:00.000Z
- Updated: 2026-09-14T22:16:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138406

FDA has approved two Gilead Sciences supplemental NDAs for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17\. Previously, the therapies were approved to treat HCV in adults. According to an FDA [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm551407.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery), Harvoni is indicated for treating pediatric patients 12 years of age and older or weighing at least 77 pounds with HCV genotype 1, 4, 5 or 6 infection without cirrhosis (liver disease) or with mild cirrhosis. Sovaldi in combination with ribavirin is indicated for treating pediatric patients 12 years of age and older or weighing at least 77 pounds with genotype 2 or 3 HCV infection without cirrhosis or with mild cirrhosis.