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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
Date Designated: 06/19/1992
Orphan Designation: For replacement therapy in patients with congenital or acquired protein C deficiency for the prevention and treatment of warfarin-induced skin necrosis during oral anticoagulation.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Immuno Clinical Research Corp.
750 Lexington Avenue, 19th Floor
New York, New York 10022
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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