Tobramycin inhalation solution - Novartis

Drug Profile

Tobramycin inhalation solution - Novartis

Alternative Names: TOBI; TOBI NextGen; Tobramycin aerosol - Chiron; Tobramycin solution for inhalation

Latest Information Update: 12 Nov 2016

Price : $50

At a glance

  • Originator Novartis
  • Class Aminoglycosides; Antibacterials; Small molecules
  • Mechanism of Action Protein 30S ribosomal subunit inhibitors
  • Orphan Drug Status

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

    Yes - Cystic fibrosis-associated respiratory tract infections
  • 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.

    No
  • New Molecular Entity No

Highest Development Phases

  • Marketed Cystic fibrosis-associated respiratory tract infections
  • Discontinued Bronchiectasis; Respiratory tract infections; Tuberculosis

Most Recent Events

  • 15 Mar 2016 Biomarkers information updated
  • 14 Apr 2015 Novartis completes enrolment in the phase III EARLY trial for Cystic fibrosis-associated respiratory tract infections (In children) in Canada, Hungary, Egypt, France, Germany, Greece, Italy, Poland, Romania, Russia and Switzerland (NCT01082367)
  • 15 Oct 2013 First generic equivalent approved in USA
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