Epclusa is a fixed-dose combination tablet containing sofosbuvir, a drug approved in 2013, and a new drug velpatasvir.
The safety and efficacy of Epclusa for 12 weeks was assessed in three phase III clinical trials of 1,558 subjects without cirrhosis or with compensated cirrhosis.
Epclusa resulted in cure rates of 95% to 99% in patients without or with mild cirrhosis after 12 weeks of treatment.
In a separate trial of patients with moderate to severe cirrhosis, cure rates of 94% were demonstrated.
Headache and fatigue were the most common side effects of Epclusa.
Gilead Sciences president and CEO John Milligan said: "Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens.
"As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible."
Gilead said Epclusa should not be administered with ribavirin in patients for whom ribavirin is contraindicated.