Otonomy Inc. files NDA at FDA for AuriPro (ciprofloxacin sustained release) to treat middle ear effusion in pediatric patients.
Otonomy, Inc.has announced that its New Drug Application (NDA) for the approval of AuriPro (ciprofloxacin sustained release) as a treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement (TTP) surgery has been accepted for filing by the FDA. The acceptance of the NDA indicates the application is sufficiently complete to permit a substantive review by the FDA.
The NDA submission is supported by data from two identical randomized, prospective, double-blind, sham-controlled Phase III clinical trials with a combined total of 532 pediatric patients. In both trials, AuriPro achieved the primary efficacy endpoint of reducing the incidence of treatment failures with statistical significance (p<0.001) and was well tolerated.>
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