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December 31, 2019Zilretta Receives Label Update
December 26, 2019 – The U.S. FDA has approved updates to the product label for Zilretta® (triamcinolone acetonide extended release injectable suspension), manufactured by Flexion Therapeutics. Zilretta is a synthetic corticosteroid indicated for use as an intra-articular injection to manage osteoarthritis pain of the knee.
Approved updates to the label include:
- Replacement of language stating that Zilretta is "not intended for repeat administration” with language stating that the “efficacy and safety of repeat administration of ZILRETTA have not been demonstrated."
- Inclusion of study description and safety data from a single-arm, open-label Phase 3 trial in which repeat administration of Zilretta was generally safe and well-tolerated.
- Removal of a potentially misleading statement that compared Zilretta to immediate release triamcinolone acetonide crystalline suspension.
- Inclusion of nonclinical toxicology data from single and repeat administration studies in non-diseased animals.
According to a press release, Flexion’s primary goal for the label update was to remove “unclear language pertaining to repeat administration” that may have been confusing.
Recommended dosing with Zilretta is 32mg administered as a single intra-articular injection in the knee. The product is not interchangeable with other formulations of injectable triamcinolone acetonide.
