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A Bioequivalence Trial of ET-104

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A Bioequivalence Trial of ET-104

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2022

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At a glance

  • Drugs Zonisamide (Primary) ; Zonisamide
  • Indications Neurological disorders; Partial epilepsies
  • Focus Pharmacokinetics; Registrational
  • Sponsors Eton Pharmaceuticals

    • Most Recent Events

    • 18 Jul 2022 According to an Eton Pharmaceuticals media release, the USA Food and Drug Administration (FDA) has approved ZONISADE (zonisamide oral suspension).
    • 30 Jul 2020 According to an Eton Pharmaceuticals media release, the company announced that it has submitted a new drug application (NDA) for zonisamide oral suspension (ET-104) to the U.S. Food & Drug Administration (FDA) for the treatment of partial seizures in patients with epilepsy.
    • 05 Mar 2020 According to an Eton Pharmaceuticals media release, the company is awaiting final FDA acceptance of its pediatric study protocol (PSP) and NDA is expected to be submitted once agreement is reached on the PSP.

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