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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
Astellas Pharma US, Inc.
1 Astellas Way
Northbrook, Illinois 60062
United States

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

Marketing approved:

1 Generic Name: gilteritinib
Trade Name: XOSPATA
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 
Exclusivity Protected 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 Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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