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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 VIIa (Recombinant)
Trade Name: NovoSeven
Date Designated: 07/16/2004
Orphan Designation: Treatment of bleeding episodes in patients with acquired inhibitors to Factor VIII or Factor IX
Orphan Designation Status: Designated/Approved
Novo Nordisk, Inc.
100 Overlook Center
Suite 200
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: Coagulation Factor VIIa (Recombinant)
Trade Name: NovoSeven
Marketing Approval Date: 10/13/2006
Approved Labeled Indication: Treatment of bleeding episodes in surgical interventions or invasive procedures in patients with acquired hemophilia
Exclusivity End Date: 10/13/2013 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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