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A Phase 3, Open-Label, Multiple-Dose, Single-Arm Exposure Study of Maxigesic IV in Patients With Acute Pain Following Orthopedic, General or Plastic Surgery

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Trial Profile

A Phase 3, Open-Label, Multiple-Dose, Single-Arm Exposure Study of Maxigesic IV in Patients With Acute Pain Following Orthopedic, General or Plastic Surgery

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jul 2022

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At a glance

  • Drugs Ibuprofen/paracetamol (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions
  • Sponsors AFT Pharmaceuticals

Most Recent Events

  • 01 Jul 2022 According to a Hyloris Pharmaceuticals media release, the FDA has only requested additional data on one remaining topic.FDA asked company to submit a report describing potential extractable and leachable compounds expected to be present in the drug product based on the drug product packaging, and company is confident that it can deliver the requested information to FDA.
  • 01 Jul 2022 According to a Hyloris Pharmaceuticals media release, company received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) on its application for the US registration of Maxigesic IV. The FDA has only requested additional data on one remaining topic.
  • 20 Jan 2022 Actual date of last participant enrolled is 30/06/2020 according to Australian New Zealand Clinical Trials Registry record.

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