FML FORTE
Details
- Status
- Prescription
- First Approved
- 1986-04-23
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
FML FORTE Approval History
What FML FORTE Treats
4 indicationsFML FORTE is approved for 4 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation of the palpebral conjunctiva
- Inflammation of the bulbar conjunctiva
- Inflammation of the cornea
- Inflammation of the anterior segment of the globe
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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.
FML FORTE FDA Label Details
ProIndications & Usage
FDA Label (PDF)FML FORTE ® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.