Development · 18 Aug 2026
LUPIN, full dossier1 publisher has reported this development. Each act of reporting is below, cited.
The US Food and Drug Administration granted final approval to Lupin Limited for an Abbreviated New Drug Application for pitolisant tablets, a generic bioequivalent to Harmony Biosciences' WAKIX indicated for treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy.
A single act of reporting so far, corroborating sources join this record as they publish.
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