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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: autologous islet transplantation (AIT)
Date Designated: 06/15/2026
Orphan Designation: prevention of diabetes due to total pancreatectomy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sernova Biotherapeutics
PO Box 29592 RPO Central Parkway
Mississauga, Ontario L5A 4H2
Canada

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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