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A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

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A Randomized, Double-Blind, Multicenter, Vehicle-Controlled Study of the Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jun 2022

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At a glance

  • Drugs Abametapir (Primary)
  • Indications Pediculosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Dr Reddys Laboratories; Hatchtech

    • Most Recent Events

    • 27 Jul 2020 According to a Dr Reddys Laboratories media release, the U.S. Food and Drug Administration (USFDA) has approved XEGLYZE (abametapir) lotion, 0.74% through a 505(b)(1) NDA.XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
    • 14 Sep 2015 According to a Dr. Reddys Laboratories media release dated 14 September 2015, Hatchtech has filed an NDA with the US FDA for Xeglyze (abametapir) lotion.
    • 18 Mar 2015 According to a Hatchtech media release, a New Drug Application (NDA) will be submitted to the U.S. Food and Drug Administration (FDA) in the third quarter of 2015.

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