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(25 Mar 2026, 09:45)

Lupin receives tentative approval from USFDA for Pitolisant tablets

Lupin announced that it has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Pitolisant tablets, 4.45 mg and 17.8 mg.


Pitolisant is indicated for the treatment of excessive daytime sleepiness in patients suffering from narcolepsy, including adults and children aged six years and above. It is also used to treat cataplexy, sudden episodes of muscle weakness, in adults with narcolepsy. The drug belongs to a class known as H3 receptor antagonists and works by regulating neurotransmitters involved in sleep-wake cycles.

The company stated that the approved product is bioequivalent to Wakix, as per the approved labeling by the U.S. regulator. The tablets will be manufactured at Lupin’s facility in Nagpur, India.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.

The counter rose 0.62% to Rs 2,346.25 on the BSE.

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