Flexion Therapeutics Announces FDA Approval of sNDA to Revise ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) Product Label
Flexion Therapeutics, Inc. (FLXN)
Last flexion therapeutics, inc. earnings: 11/7 04:01 pm
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Source: GlobeNewswire
Conference call scheduled for Friday, December 27, 2019 at 8:00 a.m. ET BURLINGTON, Mass., Dec. 26, 2019 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain. Key elements of the label update include: 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.”Inclusion of a study description and safety data from the single-arm, open-label Phase 3 repeat administration trial.Removal of a misleading statement describing a single secondary exploratory endpoint in the original Phase 3 pivotal trial which compared ZILRETTA to immediate release triamcino
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