Gilead filed the
NDA for sofosbuvir on April 8, 2013, and FDA has set a target
review date under the Prescription Drug
User Fee Act (PDUFA) of December 8, 2013.
The data submitted in this NDA support the use of sofosbuvir and ribavirin (RBV) as an all-oral therapy for patients with genotype 2 and 3 HCV infection, and for sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) for treatmentnaïve patients with genotype 1, 4, 5 and 6 HCV infection.