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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Monoclonal antibodies PM-81 and AML-2-23
Date Designated: 03/12/1990
Orphan Designation: For the exogenous depletion of CD14 and CD15 positive acute myeloid leukemic bone marrow cells from patients undergoing bone marrow transplantation.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Medarex, Inc.
67 Beaver Avenue
Annandale, New Jersey 08801
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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