Gilead Sciences, Inc. Submits New Drug Application To Japan’s Pharmaceutical And Medical Devices Agency For Fixed-Dose Combination Of Ledipasvir/Sofosbuvir For Chronic Hepatitis C Genotype 1 Infection

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the company has submitted a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults.

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