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
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
- 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).
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History