Lupin Limited recently announced it has received approval from the United States Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for midostaurin 25 mg capsules, the generic equivalent to Novartis’ Rydapt capsules.
Midostaurin is indicated for the treatment of patients with aggressive systemic mastocytosis (ASM), systemic mastocytosisMastocytosis Rare disease caused by the buildup of mast cells. Cutaneous mastocytosis primarily affects the skin and is more common in children, while systemic mastocytosis affects internal organs and is more common in adults. with associated hematological neoplasm (SM-AHN), and mast cell leukemiaMast cell leukemia The most severe subtype of SM, caused by the rapid buildup of immature mast cells in the bone marrow and blood. Mast cell leukemia accounts for less than 5% of SM cases and has a poor prognosis..
An ANDA is an abbreviated form of an NDA. In an ANDA, less information is required than in an NDA. ANDAs contain data that are submitted to the FDA for review and approval of a generic drug product.
Once the agent described in an ANDA has been approved, the applicant of the ANDA can subsequently manufacture and market the generic drug, in order to provide an effective, safe, and lower-cost alternative to the already marketed brand-name drug that it references.
Read more about SM treatment and care
Lupin Limited will market a generic equivalent of the RLD Rydapt capsules, 25 mg, according to a company statement by Novartis Pharmaceuticals Corporation, the manufacturer of the agent.
In order to be approved by the US FDA, the generic version of an agent must deliver the same amount of the active ingredient in an individual’s bloodstream in the same amount of time as the equivalent brand-name drug.
According to IQVIA MAT data from March 2024 Midostaurin capsules, 25 mg logged estimated sales of $75 million in the U.S.
