TOBREX (tobramycin)
TOBREX (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.
Details
- Status
- Prescription
- First Approved
- 1980-12-12
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS, OINTMENT
TOBREX Approval History
What TOBREX Treats
3 FDA approvalsOriginally approved for its first indication in 1980 . Covers 3 distinct patient populations.
- Other (3)
Other
(3 approvals)- • Approved indication (Dec 1980)
- • Approved indication (Nov 1981)
- • Approved indication (Dec 1984)
Novartis's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02918409 results posted | SAAVED15A0 | Ph 4 | completed | IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy |
| NCT04872400 APOW results posted | 20-2957 5672 | Ph 4 | completed | Acute Application of Antibiotic Powder in Open Fracture Wounds |
| NCT05429671 | MAUS21D.1213 | Ph 3 | completed | Antibiotic Loaded Cement After TKA |
| NCT03705962 results posted | 18088 | Ph 3 | terminated | Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures |
| NCT02873806 | GCF-039 | Ph 4 | completed | Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents |
| NCT03673956 results posted | 18-006599 | Ph 1, Ph 2 | completed | Topical Antibiotics in Chronic Rhinosinusitis |
| NCT03904836 ESRD | 2019-1619 | Ph 1 | completed | Tobramycin Administered at the Beginning of Dialysis |
| NCT01111383 CT03Ext | CMA-0631-PR-0010 Extension | Ph 3 | completed | A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® |
| NCT02207426 | TobrAir - CT0040 2013-005288-19 | Ph 1 | completed | Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™ |
| NCT00634192 | CTBM100DDE01 | Ph 3 | completed | Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin |
| NCT02269969 | 183-2014 | Ph 1, Ph 2 | completed | Once Daily Aminoglycoside Pharmacokinetics and Optimal Dosing in the Burn Population: A Prospective Study |
| NCT00705159 results posted | 550 | Ph 4 | completed | Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis |
| NCT02035488 | Tobra-02 | Ph 1, Ph 2 | completed | Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis |
| NCT01155999 results posted | LT1225-PIIIB-02/08 2008-003567-39 | Ph 3 | completed | Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children. |
| NCT01608555 | SP2 2011-001821-26 | Ph 4 | completed | Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TOBREX FDA Label Details
Indications & Usage
FDA Label (PDF)TOBREX ® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.