Flexion down on extension of FDA action date for repeat injections of Zilretta

Flexion Therapeutics (NASDAQ:FLXN) slips 2% premarket on light volume in response to an extension of the FDA’s action date for its review of its application seeking approval for repeat injections of Zilretta (triamcinolone acetonide extended-release injectable suspension) in patients with knee pain due to osteoarthritis. The PDUFA date was today.

The agency has not identified a specific revised action date, but informed the company that its review should be completed in the coming weeks.

Zilretta was first approved in the U.S. in October 2017 (single intra-articular injection).

https://seekingalpha.com/news/3505433-flexion-2-percent-premarket-extension-fda-action-date-repeat-injections-zilretta