gilteritinib
Drug Details
- Generic Name
- gilteritinib
- Brand Names
- Xospata
- Application Number
- NDA211349
- Sponsor
- Astellas Pharma US, Inc.
- NDC Codes
- 1
- Dosage Forms
- TABLET
- Routes
- ORAL
- Active Ingredients
- GILTERITINIB FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. ( 1.1 ) 1.1 Relapsed or Refractory Acute Myeloid Leukemia XOSPATA is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test.