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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: tetravalent tandem diabody binding both CD3 and CD33
Date Designated: 08/17/2017
Orphan Designation: Treatment of patients with acute myeloid leukemia (AML)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Amphivena Therapeutics, Inc.
601 Gateway Boulevard
Suite 350
South San Francisco, California 94080
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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