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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/von Willebrand factor complex (human), dried, pasteurized
Trade Name: Humate-P
Date Designated: 10/16/1992
Orphan Designation: Treatment of patients with von Willebrand's disease
Orphan Designation Status: Designated/Approved
CSL Behring
1020 First Avenue
PO Box 61501
King Of Prussia, Pennsylvania 19406
United States

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

Marketing approved:

1 Generic Name: Antihemophilic factor/von Willebrand factor complex (human), dried, pasteurized
Trade Name: Humate-P
Marketing Approval Date: 04/01/1999
Approved Labeled Indication: (1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate.
Exclusivity End Date: 04/01/2006 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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