Lupin Limited has received final approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Pitolisant Tablets in strengths of 4.45 mg and 17.8 mg. The US FDA has approved Lupin’s Pitolisant Tablets as bioequivalent to Wakix® for the indications listed in the approved product labeling. The approval strengthens Lupin’s portfolio of generic pharmaceutical products in the US market.
Pitolisant is a prescription medicine and the approved strengths will be marketed in accordance with the regulatory requirements and product labeling in the United States. The latest approval adds to Lupin’s growing portfolio of complex and specialty pharmaceutical products. The company continues to expand its presence in the US through generic formulations, complex generics, branded products, biotechnology products and active pharmaceutical ingredients.
The approval also reflects Lupin’s focus on developing and commercialising products across a range of therapeutic categories and expanding access to medicines in global markets. Lupin is headquartered in Mumbai and has a presence across more than 100 markets. The company has established a strong position in India and the United States, with products spanning respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system and women’s health therapies.
The company operates 15 manufacturing facilities and six research centres across the world, supported by a workforce of more than 26,000 employees. Lupin’s business includes branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. Its operations also extend into healthcare and technology through subsidiaries including Lupin Diagnostics, Lupin Digital Health and Lupin Manufacturing Solutions.
The company said its continued focus is on improving patient health outcomes through pharmaceutical products and healthcare solutions. The Pitolisant approval is the latest regulatory milestone for Lupin in the US and adds another product to its portfolio serving the American pharmaceutical market. The company continues to work on expanding its product pipeline and strengthening its manufacturing and research capabilities to meet demand across its key markets.
