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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
Trade Name:  N/A
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
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Aptevo Research and Development
2401 Fourth Avenue
Suite 1050
Seattle, Washington 98121

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