By: IPP Bureau
Last updated : August 17, 2026 1:48 pm
The US FDA has approved Lupin’s Pitolisant Tablets as bioequivalent to Wakix, for the indications specified in the approved product labeling
Global pharmaceutical company Lupin Limited has received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, 4.45 mg and 17.8 mg.
The US FDA has approved Lupin’s Pitolisant Tablets as bioequivalent to Wakix, for the indications specified in the approved product labeling.
The approval expands Lupin’s portfolio of generic products in the US market and marks another regulatory milestone for the company’s specialty and complex generics business.
Pitolisant is marketed under the brand name Wakix and is used for the indications outlined in its FDA-approved labeling.