Lupin Receives Tentative FDA Approval for Pitolisant Tablets
Mumbai, India, Naples, Fl, March 25, 2026 – Lupin Limited announced it 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. The product will 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.
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with operations in over 100 markets. The company focuses on pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers globally, with a workforce of over 22,000 professionals.
Wakix® is a registered trademark of Bioprojet Europe, Ltd.
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