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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: coagulation factor XIII A-subunit (recombinant)
Trade Name: TRETTEN
Date Designated: 11/06/2003
Orphan Designation: Prophylaxis of bleeding associated with congential factor XIII deficiency
Orphan Designation Status: Designated/Approved
Novo Nordisk, Inc.
800 Scudders Mill Rd.
Plainsboro, New Jersey 08536
United States

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

Marketing approved:

1 Generic Name: coagulation factor XIII A-subunit (recombinant)
Trade Name: TRETTEN
Marketing Approval Date: 12/23/2013
Approved Labeled Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.
Exclusivity End Date: 12/23/2020 
Exclusivity Protected Indication* :  Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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