Lupin receives USFDA approval for Midostaurin Capsules
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)
Lupin announced that it has received approval from the United States Food and Drug Administration (USFDA) 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 $ 75 million in the US (IQVIA MAT March 2024).
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