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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant human fucosyltransferase VI [ FTVI ] + GDP-fucose
Date Designated: 01/27/2015
Orphan Designation: To increase the activity of regulatory T-cells (Tregs) used in the prevention of graft versus host disease in patients undergoing hematopoietic stem cell transplantation
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
TargaZyme, Inc.
2100 Palomar Airport Road
Suite 214-219
Carlsbad, California 92011
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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