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Zilretta FDA Approval History

Last updated by Judith Stewart, BPharm on May 20, 2021.

FDA Approved: Yes (First approved October 6, 2017)
Brand name: Zilretta
Generic name: triamcinolone acetonide
Dosage form: Extended-Release Injectable Suspension
Company: Flexion Therapeutics, Inc.
Treatment for: Osteoarthritis

Zilretta (triamcinolone acetonide extended-release injectable suspension) is a corticosteroid intra-articular injection indicated for the management of osteoarthritis pain of the knee.

Development timeline for Zilretta

Oct  6, 2017Approval Flexion Therapeutics Announces FDA Approval of Zilretta (triamcinolone acetonide extended-release injectable suspension) for Osteoarthritis Knee Pain
Feb  7, 2017Flexion Therapeutics Announces NDA for Zilretta (FX006) Accepted by U.S. FDA
Dec 12, 2016Flexion Therapeutics Submits New Drug Application for Zilretta to Treat Knee Osteoarthritis Pain
May 26, 2016Flexion Therapeutics Receives Positive Guidance from FDA on NDA Submission for Zilretta for Osteoarthritis of the Knee

Further information

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