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HARMONY BIOSCIENCES RECEIVES U.S. FOOD AND DRUG ADMINISTRATION APPROVAL FOR WAKIX® (PITOLISANT) IN PEDIATRIC PATIENTS WITH NARCOLEPSY
WAKIX is the first-and-only FDA-approved non-scheduled treatment option for excessive daytime sleepiness in pediatric patients 6 years of age and older with
About this update from Harmony Biosciences Holdings, Inc.
[{"type":"text","content":"WAKIX is the first-and-only FDA-approved non-scheduled treatment option for excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy\n FDA granted priority review of the sNDA in February 2024\n\n\nPLYMOUTH 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","length":1111,"tagName":"div"}]