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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  bispecific T cell engager antibody construct with a half-life extension Fc moiety capable of binding to the neonatal Fc receptor
Trade Name:  N/A
Date Designated:  09/11/2019
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
Amgen Inc.
One Amgen Center Drive
Mail Stop 17-1-A
Thousand Oaks, California 91320

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