Posted by Michael Wonder on 23 Feb 2024
US FDA grants priority review to Harmony Biosciences' application for Wakix (pitolisant) in paediatric narcolepsy
21 February 2024 - Prescription Drug User Fee Act date is 21 June 2024.
Harmony Biosciences announced that the US FDA granted priority review for its supplemental new drug application for Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness or cataplexy in paediatric patients 6 years of age and older with narcolepsy.
