Posted by Michael Wonder on 12 Dec 2016
Flexion Therapeutics submits new drug application for Zilretta to treat knee osteoarthritis pain
12 December 2016 - Flexion Therapeutics today announced it has submitted a new drug application to the U.S. FDA for its lead investigational product candidate Zilretta (also known as FX006), which is being evaluated to treat patients with osteoarthritis of the knee.
Zilretta has received fast track designation from the FDA, a designation granted to drugs intended to treat serious conditions with the potential to provide meaningful improvement over existing therapies. Since the Zilretta NDA is being submitted as a 505(b)(2) application, FDA has up to 74 days to inform Flexion if the submission has been deemed complete and permits a full review.
