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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:  N/A
Date Designated:  07/13/2017
Orphan Designation:  Treatment of acute myeloid leukemia (AML)
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Astellas Pharma US, Inc.
1 Astellas Way
Northbrook, Illinois 60062

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