Flexion Therapeutics Inc. (FLXN) has sought to revise the product label for ZILRETTA to allow for repeat administration, and the FDA decision on this is expected by October 14, 2019.ZILRETTA, a sustained-release corticosteroid polymer (PLGA) formulation, was approved by the FDA in October 2017, for the management of osteoarthritis pain of the knee. Currently, ZILRETTA is administered as a single intra-articular extended-release injection of triamcinolone acetonide, to deliver 32 mg (5 mL), and is not intended for repeat administration.An exploratory analysis evaluating the efficacy of initial and repeat administration of ZILRETTA in patients with symptomatic knee osteoarthritis ranging in radiographic severity from Kellgren-Lawrence (KL) Grades 2 to 4 indicated that ZILRETTA consistently reduced OA knee pain for 12 weeks after each injection, regardless of KL Grade, according to the Company.Net sales of ZILRETTA were $22.5 million for full-year 2018, and $27.6 million in the first half of 2019.FLXN closed Friday’s (Sep.27, 2019) trading at $13.91, down 1.42%.