Search Orphan Drug Designations and Approvals
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| Generic Name: | gilteritinib | ||||||||||||||||
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| Trade Name: | XOSPATA | ||||||||||||||||
| Date Designated: | 07/13/2017 | ||||||||||||||||
| Orphan Designation: | Treatment of acute myeloid leukemia (AML) | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
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. |
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Marketing approved: |
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| 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. | |
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