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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: factor XIII concentrate (human)
Trade Name: Corifact
Date Designated: 01/16/1985
Orphan Designation: Treatment of congenital factor XIII deficiency
Orphan Designation Status: Designated/Approved
CSL Behring LLC
1020 First Ave.
PO Box 61501
King of Prussia, Pennsylvania 19406
United States

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

Marketing approved:

1 Generic Name: factor XIII concentrate (human)
Trade Name: Corifact
Marketing Approval Date: 02/17/2011
Approved Labeled Indication: For the routine prophylactic treatment of congenital factor XIII deficiency
Exclusivity End Date: 02/17/2018 
Exclusivity Protected Indication* :  
2 Generic Name: factor XIII concentrate (human)
Trade Name: Corifact
Marketing Approval Date: 01/24/2013
Approved Labeled Indication: Indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.
Exclusivity End Date: 01/24/2020 
Exclusivity Protected Indication* :  Peri-operative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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