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Bioequivalence study results for ET-101

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Trial Profile

Bioequivalence study results for ET-101

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Nov 2021

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At a glance

  • Drugs Topiramate (Primary) ; Topiramate
  • Indications Epilepsy
  • Focus Pharmacokinetics; Registrational
  • Sponsors Eton Pharmaceuticals

Most Recent Events

  • 08 Nov 2021 According to an Azurity Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved EPRONTIA™ (topiramate) oral solution, 25 mg/mL for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as preventative treatment of migraine in patients 12 year.
  • 06 Oct 2020 According to an Eton Pharmaceuticals company has submitted a NDA with Tulex Pharmaceuticals for topiramate oral solution to the U.S FDA for three indications, monotherapy for treatment of partial-onset or primary general tonic-clonic seizures in patients two years age and older; adjunctive therapy for treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older; and as preventative treatment of migraine in patients 12 year
  • 12 Aug 2020 According to an Eton pharmaceuticals media release, the company is on track submit NDA before year end.

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