Lupin Receives Tentative USFDA Approval for Generic Pitolisant Tablets
New Delhi, March 25 – Lupin Ltd announced on Wednesday that it has received tentative approval from the US health regulator for its generic version of Pitolisant tablets, indicated for the treatment of excessive daytime sleepiness.The tentative approval from the US Food and Drug Administration (USFDA) is for an abbreviated new drug application for Pitolisant Tablets in strengths of 4.45mg and 17.8mg, Lupin said in a regulatory filing.
The product will be manufactured at Lupin’s facility in Nagpur, India.
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