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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 IX
Trade Name: Mononine
Date Designated: 06/27/1989
Orphan Designation: Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B.
Orphan Designation Status: Designated/Approved
Armour Pharmaceutical Company
500 Arcola Road, P.O. Box 1200
Collegeville, Pennsylvania 19426
United States

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

Marketing approved:

1 Generic Name: Coagulation factor IX
Trade Name: Mononine
Marketing Approval Date: 08/20/1992
Approved Labeled Indication: Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.
Exclusivity End Date: 08/20/1999 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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