FDA Approves Labeling Changes for Flexion’s Zilretta

The FDA approved Flexion Therapeutics’ supplemental NDA to update the product label for Zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis knee pain.

The agency allowed the removal of language which stated that Zilretta was “not intended for repeat administration.” The updated label states that the “efficacy and safety of repeat administration of Zilretta have not been demonstrated.”

The drug was originally approved in October 2017 as the first extended-release intra-articular therapy for patients with osteoarthritis-related knee pain.