FLAREX
Details
- Status
- Prescription
- First Approved
- 1986-02-11
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
FLAREX Approval History
What FLAREX Treats
2 indicationsFLAREX is approved for 2 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation of the Conjunctiva
- Inflammation of the Cornea
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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.
FLAREX FDA Label Details
ProIndications & Usage
FDA Label (PDF)FLAREX (fluorometholone acetate ophthalmic suspension) 0.1% is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.