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FT218 FDA Approval Status

Last updated by Judith Stewart, BPharm on March 3, 2021.

FDA Approved: No
Brand name: FT218
Generic name: sodium oxybate
Company: Avadel Pharmaceuticals plc
Treatment for: Narcolepsy

FT218 (sodium oxybate) is a once-nightly formulation of the approved central nervous system depressant sodium oxybate in development for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.

Development timeline for FT218

Mar  1, 2021Avadel Pharmaceuticals Announces FDA Acceptance of New Drug Application for FT218 in Adults with Narcolepsy for the Treatment of Excessive Daytime Sleepiness and Cataplexy

Further information

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