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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Antihemophilic factor (human)
Trade Name: Alphanate
Date Designated: 01/05/1996
Orphan Designation: Treatment of von Willebrand's disease
Orphan Designation Status: Designated/Approved
Grifols Biologicals Inc.
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: Antihemophilic factor (human)
Trade Name: Alphanate
Marketing Approval Date: 01/31/2007
Approved Labeled Indication: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery
Exclusivity End Date: 01/31/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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