Posted by Michael Wonder on 08 Feb 2017
Flexion Therapeutics announces new drug application for Zilretta (FX006) accepted by U.S. Food and Drug Administration
7 February 2017 - FDA reviewing Zilretta as potential new treatment for osteoarthritis of the knee.
Flexion Therapeutics today announced that the U.S. FDA has accepted for filing the Company's new drug application for its lead investigational product candidate Zilretta (also known as FX006).
Zilretta is being evaluated as a new treatment option for patients with osteoarthritis of the knee. In accordance with the FDA's standard 10-month review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act of 6 October 2017.
