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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 coagulation factor VIII
Date Designated: 12/03/2012
Orphan Designation: Immune tolerance induction in hemophilia A patients with inhibitors
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 01/03/2020
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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