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Zilretta Approval History

FDA Approved: Yes (First approved October 6, 2017)
Brand name: Zilretta
Generic name: triamcinolone acetonide
Dosage form: Sustained-Release Intra-Articular Injection
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 History and FDA Approval Process for Zilretta

DateArticle
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
Feb 16, 2016Flexion Therapeutics Reports Primary Endpoint Met in Pivotal Phase 3 Trial of Zilretta in Knee Osteoarthritis
Dec  1, 2015Flexion Therapeutics Enrolls First Patient in Pharmacokinetic Study of Zilretta for Osteoarthritis of the Knee
Sep  8, 2015Flexion Therapeutics Reports Top-Line Data From Pivotal Phase 2b Clinical Trial for FX006
Feb 24, 2015Flexion Therapeutics Completes Enrollment in Pivotal Phase 2b Confirmatory Clinical Trial With Lead Compound FX006
Apr 19, 2013Data Presented at OARSI's 2013 World Congress on Osteoarthritis Show Flexion's FX006 Has Prolonged Therapeutic Concentration in Knee Joint

Further information

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