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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Corneal Endothelial Cells Substitute derived from human allogeneic iPS Cells (CECSi)
Date Designated: 12/20/2023
Orphan Designation: Treatment of bullous keratopathy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Caksus Bio, Inc.
Ginza Otake 2nd Floor, 1-22-11, Ginza, Chuo
Tokyo 104-0061
Japan

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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