India, June 16 -- Mallinckrodt plc announced Wednesday that the U.S. Food and Drug Administration or FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat) for the treatment of adult patients with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated.
StrataGraft is developed by Stratatech Corp., a Mallinckrodt company. The FDA granted StrataGraft regenerative medicine advanced therapy (RMAT), Priority Review and Orphan Drug designations for the indication.
Thermal burns are typically caused by direct contact with an external heat source such as steam, scalding water, hot surfaces or fire.
The current standard of care for deep par...