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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 (recombinant) formulated with sucrose reconstituted with liposome diluent
Date Designated: 04/29/2009
Orphan Designation: Treatment of hemophilia A
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/12/2014
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer HealthCare LLC
555 Whiteplains Road
Tarrytown, New York 10591
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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