Lupin bags USFDA nod for Midostaurin Capsules for Leukemia treatment
Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Midostaurin Capsules, 25 mg, to market a generic equivalent to the reference listed drug (RLD) Rydapt Capsules, 25 mg of Novartis Pharmaceuticals Corporation.
Midostaurin Capsules, 25 mg, are indicated to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
Midostaurin Capsules, 25 mg (RLD Rydapt), had estimated annual sales of USD 75 million in the U.S. (IQVIA MAT March 2024).
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Lupin is an innovation-led 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.
The Company 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. The company invested 7.8% of its revenue in research and development in FY24.
Lupin has 15 manufacturing sites, 7 research centers.
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