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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 DGN462) conjugated to the humanized anti-CD33 monoclonal antibody (Z4681A) via the sulfo-SPDB linker
Date Designated: 05/02/2018
Orphan Designation: Treatment of acute myeloid leukemia
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 02/11/2022
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
ImmunoGen, Inc.
830 Winter Street
Waltham, Massachusetts 02451
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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