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*Pitolisant is an investigational medication in the U.S that is not currently approved by the Food and Drug Administration (FDA). Harmony Biosciences, LLC, in partnership with Bioprojet, will be submitting a New Drug Application to the FDA for the evaluation of the safety and effectiveness of pitolisant. Pitolisant was approved in Europe in March 2016 for the treatment of adult patients with narcolepsy with or without cataplexy (type 1 and type 2).
