Avadel Pharmaceuticals Announces Submission of New Drug Application for FT218 to the FDA
Share: DUBLIN, Ireland, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for FT218, an investigational, once-nightly formulation of sodium oxybate designed to treat excessive daytime sleepiness and cataplexy in adults with narcolepsy. "The submission of our NDA represents a significant milestone for the Company. We look forward to working with the FDA during the NDA review process in order to get once-nightly FT218 approved and commercially available to ...