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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Indolino-benzodiazepine compound (sulfonated DGN549-C) conjugated to the humanized anti-CD123 monoclonal antibody (G4723A)
Trade Name:  N/A
Date Designated:  10/10/2018
Orphan Designation:  Treatment of acute myeloid leukemia
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
ImmunoGen, Inc.
830 Winter Street
Waltham, Massachusetts 02451

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