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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Humanized anti-human CD2 MAb
Date Designated: 09/17/1998
Orphan Designation: For the induction of donor-specific immunologic unresponsiveness resulting in prophylaxis of organ rejection without the need for chronic immunosuppressive therapy, in patients receiving allogeneic renal transplants.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Biotransplant, Inc.
Building 75, 3rd. Ave.
Charlestown Navy Yard
Charlestown, Massachusetts 02129
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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