Lupin Gets USFDA Tentative Nod for Generic Pitolisant Tablets for Sleep Disorder

Written By : sheeba farhat Published On 2026-03-30T12:30:16+05:30 | Updated On 30 March 2026 12:30 PM IST

New Delhi: Pharma major Lupin Ltd on Wednesday said it has received tentative approval from the US health regulator for its generic version of Pitolisant tablets indicated for treatment of excessive daytime sleepiness.

The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Pitolisant Tablets of strengths 4.45mg and 17.8mg, Lupin said in a regulatory filing.

This product would be manufactured at Lupin's Nagpur facility in India, it added.

Also Read: Lupin Receives USFDA EIR with VAI Status for Goa Manufacturing Plant

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Source : PTI

sheeba farhat

Sheeba Farhat Joined Medical Dialogues in 2018 to report on the latest Education news. A Graduate of the University of Delhi, she specializes in covering stories related to Medical Education updates. For inquiries or further information, you can reach her at editorial@medicaldialogues.in.