TOBREX

Post-LOE

tobramycin

Novartis

ANDAOPHTHALMICSOLUTION/DROPS1 Generic Approved

Approved

Dec 1984

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

3/8 — Basic

TOBREX (tobramycin) by Novartis. Approved for aminoglycoside antibacterial [epc]. First approved in 1984.

Drug data last refreshed 3d ago

Mechanism of Action

Pharmacologic Class:

Aminoglycoside Antibacterial

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (20)

NCT04964947Phase 3Active Not Recruiting

Tobramycin Injection to Prevent Infection in Open Fractures

Started Jan 2022

600 enrolled

Wound InfectionFractures, OpenSurgical Site Infection

NCT03721328Phase 2Completed

Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation

Started Oct 2018

15 enrolled

Prosthetic Joint Infection

NCT02819856Phase 2Completed

SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

Started Jul 2017

40 enrolled

Ototoxicity

NCT02712983Phase 2Completed

Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection

Started Feb 2017

107 enrolled

Non-cystic Fibrosis Bronchiectasis

NCT02440828Phase 4Completed

Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia

Started Mar 2015

80 enrolled

Ventilator Associated Pneumonia (VAP)

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.