TOBRADEX
Details
- Status
- Prescription
- First Approved
- 1988-08-18
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS, OINTMENT
TOBRADEX Approval History
What TOBRADEX Treats
4 indicationsTOBRADEX is approved for 4 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammatory Ocular Conditions
- Bacterial Ocular Infection
- Chronic Anterior Uveitis
- Corneal Injury
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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.
TOBRADEX FDA Label Details
ProIndications & Usage
FDA Label (PDF): TOBRADEX (tobramycin and dexamethasone ophthalmic ointment) is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.