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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: eculizumab
Trade Name: Soliris
Date Designated: 08/20/2003
Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Orphan Designation Status: Designated/Approved
Alexion Pharmaceuticals, Inc.
121 Seaport Boulevard
Boston, Massachusetts 02210
United States

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

Marketing approved:

1 Generic Name: eculizumab
Trade Name: Soliris
Marketing Approval Date: 03/16/2007
Approved Labeled Indication: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
Exclusivity End Date: 03/16/2014 
Exclusivity Protected Indication* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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