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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 [A2] homodimer, recombinant DNA origin
Date Designated: 05/21/2003
Orphan Designation: Treatment of congenital FXIII deficiency
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novo Nordisk Pharmaceuticals, INc.
100 College Road West
Princeton, New Jersey 08540
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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