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Rydapt FDA Approval History

FDA Approved: Yes (First approved April 28, 2017)
Brand name: Rydapt
Generic name: midostaurin
Dosage form: Capsules
Previous Name: PKC412
Company: Novartis Pharmaceuticals Corporation
Treatment for: Acute Myeloid Leukemia, Cutaneous Mastocytosis

Rydapt (midostaurin) is an oral, multi-targeted kinase inhibitor for the treatment of acute myeloid leukemia (AML) in newly-diagnosed adults with an FMS-like tyrosine kinase-3 (FLT3) mutation, and for the treatment of advanced systemic mastocytosis (SM), which includes aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN) and mast cell leukemia.

Development Timeline for Rydapt

DateArticle
Apr 28, 2017ApprovalFDA Approves Rydapt (midostaurin) for FLT3-Mutated Acute Myeloid Leukemia and Systemic Mastocytosis

Further information

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