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# FDA extends Flexion sNDA Review for Zilretta
- URL: https://www.fdaweb.com/fda-extends-flexion-snda-review-for-zilretta/
- Published: 2019-10-14T12:00:00.000Z
- Updated: 2026-09-15T01:56:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145239

FDA has extended the review of a Flexion Therapeutics supplemental NDA for Zilretta (triamcinolone acetonide extended-release injectable suspension) that seeks to revise the drug’s label based on results from an open-label Phase 3b clinical trial which evaluated repeat administration of Zilretta in patients with osteoarthritis knee pain. The previous review action target date was 10/14, and the agency did not provide a new action date, according to the company. FDA reportedly told the company that the review is expected to be completed in the coming weeks, and it has not asked for any additional clinical data.

Zilretta was approved 10/2017 as an intra-articular injection for managing osteoarthritis pain in the knee. It uses the company’s proprietary microsphere technology combining triamcinolone acetonide, a commonly administered, short-acting corticosteroid, with a poly lactic-co-glycolic acid matrix to provide extended pain relief, the company says.