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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  gilteritinib
Trade Name:  Xospata
Date Designated:  07/13/2017
Orphan Designation:  Treatment of acute myeloid leukemia (AML)
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  11/28/2018 
Approved Labeled Indication:  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.
Exclusivity End Date:   11/28/2025
Astellas Pharma US, Inc.
1 Astellas Way
Northbrook, Illinois 60062

The sponsor address listed is the last reported by the sponsor to OOPD.