title: Finafloxacin: first global approval.
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.
authors: Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand, dru@adis.com.
authors: Kate
authors: K
authors: McKeage
mesh_terms: D000818:Animals; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D017277:Drug Approval; D024841:Fluoroquinolones / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D038622:Internationality; D008826:Microbial Sensitivity Tests; D010032:Otitis Externa / Q000188:drug therapy*; D014552:Urinary Tract Infections / Q000188:drug therapy
chemical_list: D000900:Anti-Bacterial Agents; D024841:Fluoroquinolones; C560572:finafloxacin