Lupin gets U.S FDA nod for Pitolisant tablets
Lupin has received U.S. FDA approval for its generic version of Pitolisant tablets, used to treat narcolepsy-related symptoms. The generic drug is confirmed as bioequivalent to the branded medication Wakix.
Why it matters
Generic approvals increase market competition and lower healthcare costs for patients requiring specialized treatment.
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 people 6 years of age and older with narcolepsy.
business (general) / pharmaceutical / generic drugs / health
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