A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Trial Profile

A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Phase 3 Study of OTO-201 Given as a Single Administration for Treatment of Acute Otitis Externa

Completed
Phase of Trial: Phase III

Latest Information Update: 02 Mar 2018

At a glance

  • Drugs Ciprofloxacin (Primary)
  • Indications Otitis externa
  • Focus Registrational; Therapeutic Use
  • Sponsors Otonomy
  • Most Recent Events

    • 02 Mar 2018 According to an Otonomy media release, the U.S. Food and Drug Administration (FDA) has approved OTIPRIO (ciprofloxacin otic suspension) 6% for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.
    • 18 Jul 2017 According to an Otonomy media release, the US FDA has accepted the supplemental NDA (sNDA) for the approval of OTIPRIO as a treatment of acute otitis externa (AOE) with a Prescription Drug User Fee Act (PDUFA) action date of March 2, 2018.
    • 04 May 2017 According to an Otonomy media release, based on the data from the study the company has recently submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA).
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