Drug Profile


Alternative Names: ARB-FV0127; Factive; Gemifloxacin mesylate; LB 20304; LB 20304a; SB 265805

Latest Information Update: 04 Nov 2017

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At a glance

  • Originator LG Life Sciences
  • Developer Abbott Canada; Chiesi USA; LG Chem; Menarini; Pfizer
  • Class Antibacterials; Cyclopropanes; Fluoroquinolones; Imines; Naphthyridines; Pyrrolidines; Small molecules
  • Mechanism of Action DNA gyrase inhibitors; DNA topoisomerase IV inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute exacerbations of chronic bronchitis; Acute sinusitis; Bacterial infections; Community-acquired pneumonia; Otitis media; Respiratory tract infections; Urinary tract infections

Most Recent Events

  • 04 Nov 2017 No recent reports of development identified for preclinical development in Bacterial-infections in USA (IV)
  • 26 Jul 2016 The US FDA approved label for gemifloxacin carries a boxed warning
  • 22 Oct 2014 Launched prior to this date for Bacterial infections in Brazil, Chile, Mexico, South Africa & Turkey (PO)
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