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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Recombinant Bispecific antibody targeting CD123 and CD3
Date Designated: 11/26/2019
Orphan Designation: Treatment of acute myelogenous leukemia
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Aptevo Research and Development
2401 Fourth Avenue
Suite 1050
Seattle, Washington 98121
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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