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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: prothrombin complex concentrate, human-lans
Trade Name: Balfaxar
Date Designated: 02/01/2008
Orphan Designation: Reversal of anticoagulation therapy in patients needing treatment of serious or life threatening bleeding and/or needing urgent surgery or invasive procedures
Orphan Designation Status: Designated/Approved
Octapharma USA, Inc.
121 River Street
12th Floor
Hoboken, New Jersey 07030
United States

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

Marketing approved:

1 Generic Name: prothrombin complex concentrate, human-lans
Trade Name: Balfaxar
Marketing Approval Date: 07/21/2023
Approved Labeled Indication: urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for an urgent surgery/invasive procedure
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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