References

1. FLOXIN Otic, sNDA 20-799, Approved September 30, 2003.
2. Based on overall responses of twice-daily ofloxacin-treated patients in Phase III clinical trials (NDA 20-799).
3. Goldblatt EL, Dohar J, Nozza RJ, Nielsen RW, et al. Topical ofloxacin versus systemic amoxicillin/clavulanate in purulent otorrhea in children with tympanostomy tubes. Intl J Ped Otorhinolaryngol. 1998;46:91-101.
4. Ohyama, M, Furuta, S, Veno, K, et al. Ofloxacin otic solution in patients with otitis media: an analysis of drug concentrations. Arch of Otolaryngol. 1999;125:337-340.
5. Consensus Panel, Hannley MT, Denneny JC, Holzer SS. Otolaryngology-Head and Neck Surgery. 2000;122(6):934-940.
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