Flexion Therapeutics announces extended FDA review of supplemental new drug application for Zilretta to treat osteoarthritis of the knee.
Flexion Therapeutics, Inc. announced that the FDA has informed the company it needs additional time to complete the review of the supplemental New Drug Application (sNDA) for Zilretta (triamcinolone acetonide extended-release injectable suspension). The anticipated Prescription Drug User Fee Act (PDUFA) action date was October 14, 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.
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