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Harmony Biosciences: FDA grants priority review for sNDA for WAKIX
The Fly

Harmony Biosciences: FDA grants priority review for sNDA for WAKIX

Harmony Biosciences announced that the U.S. FDA granted priority review for its supplemental New Drug Application for WAKIX tablets for the treatment of excessive daytime sleepiness or cataplexy in pediatric patients 6 years of age and older with narcolepsy. The FDA has set a Prescription Drug User Fee Act, or target action date, of June 21, 2024.

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