Search Orphan Drug Designations and Approvals
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| Generic Name: | 6-{[(1R,2S)-2-aminocyclohexyl]amino}-7-fluoro-4-(1-methyl-1H-pyrazol-4-yl)-1,2-dihydro-3H-pyrrolo[3,4-c]pyridin-3-one monocitrate |
|---|---|
| Date Designated: | 10/03/2017 |
| Orphan Designation: | Treatment of acute myeloid leukemia (AML) |
| Orphan Designation Status: | Designated |
| FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
| Sponsor: |
Takeda Development Center Americas, Inc. 95 Hayden Avenue Lexington, Massachusetts 02421 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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