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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 skin-derived ABCB5-positive mesenchymal stem cells
Trade Name:  N/A
Date Designated:  05/01/2019
Orphan Designation:  Treatment of Epidermolysis Bullosa
Orphan Designation Status:  Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Marketing Approval Date:  N/A
Approved Labeled Indication:  
Exclusivity End Date:    N/A
Exclusivity Protected Indication*:  
RHEACELL GmbH & Co. KG
Im Neuenheimer Feld 517
Heidelberg
Germany

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.
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