Flexion Receives Positive Guidance From FDA On NDA Submission For Zilretta

(RTTNews) - Flexion Therapeutics Inc. (FLXN) said that it received written responses from the U.S. Food & Drug Administration to questions the company had submitted in advance of a pre-NDA meeting regarding Flexion's lead product candidate, Zilretta (also known as FX006).

The FDA clearly indicated in its responses that the safety and efficacy data from the registration program for Zilretta are "acceptable to support filing of an NDA submission." Based on this positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official meeting minutes.