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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: combination of MSCs derived from allogeneic bone marrow and transduced with bacterial cytosine deaminase gene (MSC11FCD), and oral 5-FC
Date Designated: 02/27/2026
Orphan Designation: treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
CELLeBRAIN Co., Ltd.
304-29
154 Anjeon-ro Deokjin-gu
Jeonju-si, Jeollabuk-do 54871
South Korea

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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