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A phase 3 study compared the efficacy and tolerability of AMP-100 to current standards of care

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Trial Profile

A phase 3 study compared the efficacy and tolerability of AMP-100 to current standards of care

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2023

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At a glance

  • Drugs Chloroprocaine (Primary)
  • Indications Anaesthesia
  • Focus Therapeutic Use
  • Sponsors Sintetica

    • Most Recent Events

    • 22 Feb 2022 According to a Harrow Health media release, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for AMP-100, for ocular surface anesthesia and intraoperative pain management during ocular surgery. The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of October 16, 2022.
    • 10 Aug 2021 According to a Harrow Health media release, company expects to submit NDA to FDA for AMP-100 in the next few months.
    • 04 Aug 2021 New trial record

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