Posted by Michael Wonder on 01 Mar 2021
Avadel Pharmaceuticals announces FDA acceptance of new drug application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy
1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021.
Avadel Pharmaceuticals today announced that the U.S. FDA has accepted for review the Company’s new drug application for FT218, an investigational, once nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in adults with narcolepsy.
