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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: human fibrinogen concentrate, pasteurized
Trade Name: RiaSTAP
Date Designated: 03/13/2008
Orphan Designation: Treatment of fibrinogen deficient patients.
Orphan Designation Status: Designated/Approved
CSL Behring, LLC
1020 First Avenue
P.O. 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: human fibrinogen concentrate, pasteurized
Trade Name: RiaSTAP
Marketing Approval Date: 01/16/2009
Approved Labeled Indication: Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)
Exclusivity End Date: 01/16/2016 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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