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A third phase III safety and pharmacokinetics study to of HTX-011

Trial Profile

A third phase III safety and pharmacokinetics study to of HTX-011

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 15 Jan 2021

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At a glance

  • Drugs Bupivacaine/meloxicam (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions; Pharmacokinetics; Registrational
  • Most Recent Events

    • 11 Jan 2021 According to a Heron Therapeutics media release, the New Drug Application (NDA) was resubmitted to the U.S. FDA for HTX-011, for the management of postoperative pain. This resubmission is under review. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of May 12, 2021.
    • 19 Feb 2020 According to an Heron Therapeutics media release, the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for HTX-011 by up to three months. The new PDUFA goal date is June 26, 2020.
    • 14 Aug 2017 New trial record
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