Lupin Receives Tentative U.S. FDA Approval for Pitolisant Tablets
Filing Summary
Lupin Limited has obtained tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Pitolisant Tablets in 4.45mg and 17.8mg dosages. The tablets are bioequivalent to Wakix® and will be manufactured at Lupin’s Nagpur facility in India. This approval is part of Lupin’s strategy to expand its pharmaceutical offerings in the U.S. market. Lupin is a global pharmaceutical company with a strong presence in multiple therapy areas, including respiratory and cardiovascular.
Lupin Limited announced that it has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, available in 4.45mg and 17.8mg dosages. The approval was granted on March 25, 2026, and the tablets are deemed bioequivalent to Wakix®, as per the approved labeling.
The Pitolisant Tablets will be manufactured at Lupin’s facility located in Nagpur, India. This facility is part of Lupin’s extensive manufacturing network, which includes 15 sites globally. The tentative approval signifies a step towards full approval, pending the resolution of any patent or exclusivity issues.
Lupin specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company distributes its products in over 100 markets worldwide, with a significant presence in the United States and India.
The company is involved in multiple therapy areas, such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin’s strategic focus includes improving patient health outcomes through its subsidiaries, which include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company is committed to expanding its portfolio in the U.S. market, leveraging its manufacturing and research capabilities. Lupin operates seven research centers globally and employs over 22,000 professionals dedicated to advancing healthcare solutions.