Lupin Gets USFDA Nod for Sleepiness Drug
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Lupin receives tentative USFDA approval for generic Pitolisant tablets, treating excessive daytime sleepiness. Manufactured in Nagpur, India.
New Delhi, Mar 25 (PTI) 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.
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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