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FDA Approves Otiprio (ciprofloxacin otic suspension) for the Treatment of Pediatric Patients Undergoing Tympanostomy Tube Placement Surgery
Posted 11 Dec 2015 by Drugs.com
SAN DIEGO, Dec. 11, 2015 (GLOBE NEWSWIRE) – Otonomy, Inc. (Nasdaq:OTIC), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced that the U.S. Food and Drug Administration (FDA) has approved Otiprio (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is a single-dose, physician-administered antibacterial and the first product approved by the FDA for this indication. "The approval of Otiprio, our first product, is a landmark moment in the history of Otonomy, and provides important validation for our proprietary drug delivery technology that combines a thermosensitive gel with drug microparticles to enable single dose treatment by a physician," said David A. Weber, Ph.D., ... Read more