Global pharma major Lupin Limited on Thursday 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.
According to the company’s statement, the approval has been granted 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).
