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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Genetically engineered (alpha-1,3-galactosyltransferase knock-out}, live cell porcine (Sus scrofa) xenotransplantation skin graft
Date Designated: 06/14/2021
Orphan Designation: Treatment of severe and extensive, deep partial and full-thickness burn wounds requiring hospitalization, surgical excision, and skin grafting.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
XenoTherapeutics, Inc.
359 Newbury St
Unit 526
Boston, Massachusetts 02115
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.