FML FORTE (fluorometholone)
FML FORTE is indicated for the treatment of Inflammation of the palpebral conjunctiva; Inflammation of the bulbar conjunctiva; Inflammation of the cornea; Inflammation of the anterior segment of the globe.
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
FML FORTE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to FML FORTE
3 of 4FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01448213 results posted | 2011-0329 | Ph 2 | completed | Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK) |
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
Indications & Usage
FDA Label (PDF)FML FORTE is indicated for the treatment of 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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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.