Dec. 26, 2019: Flexion Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to revise the product label for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain.
Some important elements of the label update include Removal of language which stated that ZILRETTA was “not intended for the repeat administration.” The restructured label states that the “efficacy and the safety of repeat administration of ZILRETTA have not been demonstrated.”
Removal of the misleading statement describing a single secondary tentative endpoint in the original Phase 3 pivotal trial which compared ZILRETTA to immediate release triamcinolone acetonide crystalline suspension.
ZILRETTA is indicated as an intra-articular injection and is contraindicated in patients who are hypersensitive to triamcinolone acetonide, corticosteroids or any components of the product.
ZILRETTA has not be evaluated and should not be administered by epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, or subcutaneous routes. It should not be considered safe for epidural or intrathecal administration. https://fda.einnews.com/pr_news/505807715/flexion-therapeutics-announces-fda-approval-of-snda-to-revise-zilretta-triamcinolone-acetonide-extended-release-injectable-suspension-product-label
