Lupin Receives Tentative Approval from U.S. FDA for Pitolisant Tablets

MUMBAI, India and NAPLES, Fla., March 25, 2026 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it 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.

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 22,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

*Safe Harbor Statement
Wakix® is a registered trademark of Bioprojet Europe, Ltd.

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SOURCE Lupin Pharmaceuticals, Inc.