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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Protein C concentrate
Trade Name: Ceprotin
Date Designated: 06/23/1992
Orphan Designation: For replacement therapy in congenital protein C deficiency for the prevention and treatment of thrombosis, pulmonary emboli, and purpura fulminans.
Orphan Designation Status: Designated/Approved
Baxalta US, Inc.
One Baxter Way
West Lake Village, California 91362
United States

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

Marketing approved:

1 Generic Name: Protein C concentrate
Trade Name: Ceprotin
Marketing Approval Date: 03/30/2007
Approved Labeled Indication: Prevention and treatment of venous thrombosis and purpura fulminans
Exclusivity End Date: 03/30/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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