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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  bilayer, engineered collagen hydrogel-based skin graft composed of autologous keratinocytes and fibroblasts
Trade Name:  Primeskin
Date Designated:  09/06/2016
Orphan Designation:  Treatment of partial deep dermal and full thickness burn wounds
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
University Children's Hospital Zurich
Tissue Biology Research Unit
7 August-Forel-Strasse
Zürich
Switzerland

The sponsor address listed is the last reported by the sponsor to OOPD.
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