Lupin gets USFDA nod for narcolepsy drug Pitolisant

Drugmaker Lupin has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg. The USFDA approved the generic as bioequivalent to Harmony Biosciences' brand drug Wakix.

Wakix is a prescription medicine used to treat excessive daytime sleepiness or cataplexy in people aged 6 years and older with narcolepsy. The approval covers the indications listed in the branded drug's labelling.

Lupin announced the development on August 17, 2026. The company did not immediately disclose a launch timeline or commercial partner for the product.