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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 cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
Trade Name: StrataGraft
Date Designated: 05/21/2012
Orphan Designation: Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting
Orphan Designation Status: Designated/Approved
Stratatech Corporation, a Mallinckrodt company
440 Route 22 East
Bridgewater, New Jersey 08807
United States

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

Marketing approved:

1 Generic Name: allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
Trade Name: StrataGraft
Marketing Approval Date: 06/15/2021
Approved Labeled Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)
Exclusivity End Date: 06/15/2028 
Exclusivity Protected Indication* :  Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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