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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 (human)
Trade Name: AlphaNine
Date Designated: 07/05/1990
Orphan Designation: For use as replacement therapy in patients with hemophilia B for the prevention and control of bleeding episodes, and during surgery to correct defective hemostasis.
Orphan Designation Status: Designated/Approved
Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032
United States

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

Marketing approved:

1 Generic Name: Coagulation Factor IX (human)
Trade Name: AlphaNine
Marketing Approval Date: 12/31/1990
Approved Labeled Indication:
Exclusivity End Date: 12/31/1997 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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