• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
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 Terapie Avanzate S.r.l.
Via Glauco Gottardi 100

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.