Posted by Michael Wonder on 10 Jun 2020
Mallinckrodt completes rolling submission of biologics license application for StrataGraft regenerative skin tissue to U.S. FDA
9 June 2020 - StrataGraft skin tissue is in development as potential new treatment option for patients with deep partial-thickness thermal burns.
Mallinckrodt today announced that Stratatech, a Mallinckrodt company, has completed its rolling submission of a biologics license application to the U.S. FDA for StrataGraft, a regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns.
The company previously announced initiation of the rolling submission in April. StrataGraft skin tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.
