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A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines

Trial Profile

A Multi-center, Open Label, Multiple Dose, Phase II Trial to Demonstrate the Safety of DWP-450 in Adult Subjects for Treatment of Moderate-to-severe Glabellar Lines

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 25 Apr 2019

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Glabellar lines
  • Focus Adverse reactions
  • Acronyms EV-004
  • Sponsors Evolus
  • Most Recent Events

    • 01 Feb 2019 According to an Evolus media release, the U.S. Food and Drug Administration has approved Jeuveau for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
    • 29 Aug 2018 According to an Evolus media release, the U.S. Food and Drug Administration has accepted the Biologics License Application for prabotulinumtoxinA (DWP-450), resubmitted by the company and assigned a February 2, 2019 action date per the Prescription Drug User Fee Act (PDUFA).
    • 02 Aug 2018 According to a Evolus media release, the company has announced that they are resubmitting the BLA for DWP-450. The BLA now includes additional data required by the FDA for the completion of review of DWP-450 BLA. Notice of the FDA's acceptance of the resubmission and the assignment of a new FDA action date is expected in September 2018.
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