Posted by Michael Wonder on 14 Oct 2019
Flexion Therapeutics announces extended FDA review of supplemental new drug application for Zilretta
14 October 2019 - Flexion Therapeutics today announced that the U.S. FDA has informed the company it needs additional time to complete the review of the supplemental new drug application for ZILRETTA (triamcinolone acetonide extended-release injectable suspension).
The anticipated Prescription Drug User Fee Act action date was today, 14 October 2019.
Although the FDA did not provide a new action date, the FDA informed the company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional clinical data and the company has provided the FDA with all information requested to date.
