Lupin gets U.S FDA nod for Pitolisant tablets

Drugmaker Lupin on Monday said it has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg.

The U.S. FDA has approved the company’s generic as bioequivalent to Harmony Biosciences’ Wakix for the indications in the approved labeling. A prescription medicine, Wakix is used to treat excessive daytime sleepiness (EDS) or cataplexy in residents 6 years of age and older with narcolepsy.