Lupin Gets USFDA Tentative Nod for Generic Pitolisant Tablets for Sleep Disorder
Written By : sheeba farhat
Published On 2026-03-30 07:00 GMT | Update On 2026-03-30 07:00 GMT
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.
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