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Lupin Gets USFDA Nod for Generic Tablets To Treat Excessive Daytime Sleepiness
Authored By PTI | Last Modified: Aug 17, 2026 02:00 PM IST
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New Delhi: Pharma major Lupin Ltd on Monday 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.
(Disclaimer: Except for the headline, this article has not been edited by HDFC Sky editorial team and is auto-generated from PTI feed.)
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