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An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

Trial Profile

An Open-label Study to Assess the Safety of Repeat Administration of FX006 to Patients With Osteoarthritis of the Knee

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2019

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At a glance

  • Drugs Triamcinolone (Primary)
  • Indications Osteoarthritis
  • Focus Adverse reactions; Registrational
  • Sponsors Flexion Therapeutics
  • Most Recent Events

    • 14 Oct 2019 According to a Flexion Therapeutics media release, the anticipated Prescription Drug User Fee Act (PDUFA) action date was today, October 14, 2019 however the U.S. Food and Drug Administration (FDA) has informed the company it needs additional time to complete the review of the supplemental New Drug Application (sNDA) for ZILRETTA (triamcinolone acetonide extended-release injectable suspension) and the review is expected to be completed in the coming weeks.
    • 15 Jul 2019 According to a Flexion Therapeutics media release, new findings from the study were presented at the American Orthopaedic Society Sports Medicine (AOSSM) conference in Boston, 2019.
    • 15 Jul 2019 Results presented in a Flexion Therapeutics media release.
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