Harmony Biosciences receives US FDA approval for Wakix (pitolisant) in paediatric patients with narcolepsy

Harmony Biosciences

24 June 2024 - FDA granted priority review of the sNDA in February 2024.

Harmony Biosciences today announced that the US FDA has approved its supplemental new drug application for Wakix (pitolisant) tablets for the treatment of excessive daytime sleepiness in paediatric patients 6 years of age and older with narcolepsy.

Read Harmony Biosciences press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Paediatrics