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17/08/2026 17:58

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Lupin gets USFDA approval for Generic Drug to treat excessive daytime sleepiness

Lupin Ltd has received final approval from the US Food and Drug Administration (USFDA) for its generic version of Pitolisant tablets, a medicine indicated for treating excessive daytime sleepiness.

The approval covers Pitolisant tablets in strengths of 4.45 mg and 17.8 mg, Lupin said in a regulatory filing on Monday.

According to the company, the approved tablets have been determined to be bioequivalent to Wakix, the reference drug. The approval was granted for Lupin’s abbreviated new drug application (ANDA).