HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS WITH NARCOLEPSY

June 24, 2024

https://www.prnewswire.com/news-releases/harmony-biosciences-receives-us-food-and-drug-administration-approval-for-wakix-pitolisant-in-pediatric-patients-with-narcolepsy-302179754.html

PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ — Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. The FDA separated the submission into two sNDAs for administrative purposes to issue an approval for the treatment of EDS and a complete response for the treatment of cataplexy in pediatric patients (6 to <18 years of age) with narcolepsy.  

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