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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: allogeneic self-organized three-dimensional retinal tissue-sheet derived from human induced pluripotent stem cells (iPSCs) that include photoreceptor precursors
Date Designated: 03/12/2026
Orphan Designation: treatment of retinitis pigmentosa
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sumitomo Pharma America Inc
84 Waterford Drive
Marlborough, Massachusetts 01752
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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