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# Otonomy File sNDA for Otiprior in Swimmer’s Ear
- URL: https://www.fdaweb.com/otonomy-file-snda-for-otiprior-in-swimmers-ear/
- Published: 2017-07-18T12:00:00.000Z
- Updated: 2026-09-14T22:34:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139161

FDA has accepted an Otonomy supplemental NDA seeking approval of Otiprior (ciprofloxacin otic suspension) as a treatment for acute otitis externa (swimmer’s ear). The agency has set a user fee review action target date of 3/2/2018\. Otiprio is a fluoroquinolone antibacterial currently indicated for treating pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

  
The submission is supported by data from a pivotal Phase 3 clinical trial of Otiprio in 262 pediatric and adult patients with swimmer’s ear. The trial met its primary endpoint showing a statistically significant increase in clinical cure rate compared to sham (no treatment) after eight days, according to the company.