Pharma major Lupin Ltd on Monday, August 17 said it has received final approval from the US health regulator for the generic version of Pitolisant tablets indicated to treat excessive daytime sleepiness.
The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pitolisant Tablets of strengths 4.45 mg and 17.8 mg, Lupin Ltd said in a regulatory filing.
The USFDA has approved Lupin's Pitolisant tablets, 4.45 mg and 17.8 mg, as bioequivalent to Wakix, the company said.
Wakix is a prescription medicine used to treat excessive daytime sleepiness (EDS) of Harmony Biosciences.