Posted by Michael Wonder on 16 Sep 2020
MediWound announces FDA acceptance of biologics license application for NexoBrid for the treatment of severe thermal burns
16 September 2020 - MediWound today announced that the U.S. FDA has accepted for review its recently submitted biologics license application for NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.
The FDA assigned a Prescription Drug User Fee Act target date of 29 June 2021.
In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.
