Overview
Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (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.
Indication
Midostaurin capsules, 25 mg, are indicated to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM-AHN), or mast cell leukaemia (MCL).
Estimated Annual Sales
Midostaurin capsules, 25 mg (RLD Rydap), had estimated annual sales of USD 75 million in the US (IQVIA MAT March 2024).
Lupin
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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
