25-Mar-2026      09:35

Lupin receives USFDA tentative approval for Pitolisant Tablets, 4.45mg and 17.8mg

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, 4.45mg and 17.8mg. This product would be manufactured at Lupin's Nagpur facility in India.

The U.S. FDA has tentatively approved Lupin's Pitolisant Tablets 4.45mg and 17.8 mg as bioequivalent to Wakix' for the indication in the approved labeling.

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