Finafloxacin: First Global Approval

doi:10.1007/s40265-015-0384-z

Paper

Finafloxacin: First Global Approval

Published Mar 26, 2015 · K. McKeage

Drugs

Q1 SJR score

45

Citations

4

Influential Citations

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Abstract

Finafloxacin is a fluoroquinolone antimicrobial agent that exhibits optimum efficacy in slightly acidic environments. It is being developed by MerLion Pharmaceuticals to treat serious bacterial infections associated with an acidic environment, including urinary tract infections and Helicobacter pylori infections. An otic suspension of finafloxacin (Xtoro™), developed by Alcon (a division of Novartis), was recently approved in the USA for the treatment of acute otitis externa, and a Common Technical Document for this indication was also filed in Canada. Oral and/or intravenous formulations are in phase I and II evaluation in uncomplicated urinary tract infections (Germany and Singapore), complicated urinary tract infections and pyelonephritis (Germany and Poland) and H. pylori infection (Germany). This article summarizes the milestones in the development of finafloxacin leading to this first approval for otitis externa.

Study Snapshot

Finafloxacin, a fluoroquinolone antimicrobial agent, has been approved for treating acute otitis externa in the USA, marking its first global approval.

PopulationOlder adults (50-71 years)

Sample size24

MethodsObservational

OutcomesBody Mass Index projections

ResultsSocial networks mitigate obesity in older groups.

Finafloxacin: First Global Approval

References

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