TOBREX
Details
- Status
- Prescription
- First Approved
- 1980-12-12
- Routes
- OPHTHALMIC
- Dosage Forms
- OINTMENT, SOLUTION/DROPS
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)
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
ProIndications & 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.