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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
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
Curtiss AG
Grabenstrasse 11
Schlieren 8952

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.