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Pitolisant Approval Status

FDA Approved: No
Generic name: pitolisant
Company: Harmony Biosciences, LLC
Treatment for: Narcolepsy

Pitolisant is a potent and highly selective histamine 3 (H₃) receptor antagonist/inverse agonist in development for the treatment of excessive daytime sleepiness (EDS) and/or cataplexy in adult patients with narcolepsy.

Development Status and FDA Approval Process for pitolisant

DateArticle
Feb 12, 2019Harmony Biosciences Announces File Acceptance Of Its New Drug Application For Pitolisant
Sep 11, 2018Harmony Biosciences Presents 5-Year Data On Pitolisant At International Narcolepsy Symposium

Further information

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