Mumbai: Global pharma major, Lupin Limited, has announced that the company has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Obeticholic Acid Tablets, 5 mg and 10 mg.
Obeticholic acid tablets are used for treating primary biliary cholangitis. Primary biliary cholangitis is an autoimmune disease of the liver that destroys bile ducts, which allows bile to stay in the liver and cause damage.
The product is a generic equivalent of Ocaliva Tablets, 5 mg and 10 mg, of Intercept Pharmaceuticals, Inc.
Obeticholic Acid Tablets (RLD Ocaliva) had estimated annual sales of USD 255 million in the U.S. (IQVIA MAT December 2022).
Lupin is a transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
Lupin specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. It invested 8.7% of its revenue in research and development in FY22.