Harmony Biosciences Receives FDA Orphan Drug Designation For Pitolisant
FDA Confirms Paragraph IV Patent Litigation for Pitolisant Hydrochloride Tablets
SHANGHAI, July 4, 2023 /PRNewswire/ -- RareStone Group, a rare disease-focused company aiming to establish the first rare disease ecosystem in China, announced that on June 30, the Chinese National Medical Products Administration (NMPA) approved pitolisant (Wakix) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. In China, pitolisant is the first approved innovative drug for narcolepsy and the only non-scheduled drug with narcolepsy indication.