Lupin Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Pitolisant Tablets, available in 4.45 mg and 17.8 mg strengths. These tablets are bioequivalent to Wakix® and approved for specific indications. This marks a significant milestone for Lupin in the U.S. market, expanding its therapeutic offerings in the central nervous system segment.
FDA Approval for Pitolisant Tablets
Global pharmaceutical major Lupin Limited announced today, August 17, 2026, that it has secured final approval from the United States Food and Drug Administration (U.S. FDA). The approval is for its Abbreviated New Drug Application (ANDA) for Pitolisant Tablets, offered in 4.45 mg and 17.8 mg dosages. This significant regulatory clearance allows Lupin to market its Pitolisant Tablets in the U.S. market.
Market Significance and Bioequivalence
The U.S. FDA has confirmed that Lupin’s Pitolisant Tablets are bioequivalent to the reference drug, Wakix®, for the indications specified in the approved labeling. This approval represents a key advancement for Lupin, particularly in the central nervous system (CNS) therapeutic area. The company’s robust pipeline and established presence in the U.S. market are expected to be further strengthened by this new product.
About Lupin Limited
Lupin Limited is a leading global pharmaceutical company headquartered in Mumbai, India. With a presence in over 100 markets, Lupin specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has a strong footprint in India and the U.S., catering to diverse therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, CNS, and women’s health. Lupin operates 15 state-of-the-art manufacturing sites and 6 research centers globally, employing over 26,000 professionals dedicated to improving patient health outcomes.
Source: BSE
