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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ex vivo expanded autologous human corneal epithelial cells containing stem cells
Date Designated: 04/26/2018
Orphan Designation: Treatment of limbal stem cell deficiency
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Holostem S.r.l.
Via Glauco Gottardi 100
Modena 41125
Italy

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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