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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 human monoclonal antibody against human complement component C5a
Date Designated: 10/06/2016
Orphan Designation: Treatment of acute graft versus host disease
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/21/2017
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Alexion Pharmaceuticals, Inc.
100 College Street
New Haven, Connecticut 06510
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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