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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: N-[3-(4',5'-bipyrimidin-2-ylamino)-4-methylphenyl]-4-{[(3S)-3-(dimethylamino)pyrrolidin-1-yl]methyl}-3-(trifluoromethyl)benzamide
Date Designated: 12/27/2006
Orphan Designation: Treatment of Philadelphia chromosome-positive chronic myelogenous leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CytRx Corporation
11726 San Vicente Blvd.
Los Angeles, California 90049
United States

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

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.