Drug Profile


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

Latest Information Update: 02 Aug 2016

Price : $50

At a glance

  • Originator LG Life Sciences
  • Developer Abbott Canada; Chiesi USA; LG Life Sciences; 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • 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

  • 26 Jul 2016 The US FDA approved label for gemifloxacin carries a boxed warning
  • 22 Oct 2014 Launched prior to this date for Respiratory tract infections in China (PO)
  • 22 Oct 2014 Launched prior to this date for Bacterial infections in Brazil, Chile, Mexico, South Africa & Turkey (PO)
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at so we can help.

Back to top