Lupin Secures FDA Approval for Generic Pitolisant Tablets
Mumbai-based pharmaceutical giant Lupin Limited has received final U.S. Food and Drug Administration approval for its Abbreviated New Drug Application regarding Pitolisant tablets. The regulatory green light covers both 4.45 mg and 17.8 mg dosages, allowing the company to introduce a bioequivalent version of the treatment to the American market.
The FDA confirmed that Lupin’s generic formulation is therapeutically equivalent to Wakix, a product currently registered to Bioprojet Europe, Ltd. This approval enables the company to expand its presence in the central nervous system therapy sector, a key segment of its global portfolio.
Lupin operates an extensive network spanning 15 manufacturing sites and 6 research centers, employing more than 26,000 people worldwide. By adding this generic to its U.S. offerings, the company reinforces its strategy of providing affordable alternatives across complex therapy areas including cardiovascular, respiratory, and diabetic care.
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