Posted by Michael Wonder on 10 Aug 2020
Mallinckrodt announces U.S. FDA filing acceptance of biologics license application for StrataGraft regenerative skin tissue for treatment of adults with deep partial-thickness thermal burns
10 August 2020 - StrataGraft skin tissue, if approved, could reduce or eliminate the need for auto-grafting of healthy skin to treat burn wounds.
Mallinckrodt today announced that the U.S. FDA has accepted for review the Stratatech biologics license application for StrataGraft, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns.
The FDA granted the application priority review and assigned a Prescription Drug User Fee Act target date of 2 February 2021.
