FLUOROMETHOLONE · AMNEAL
Fluorometholone ophthalmic suspension 0.1% is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Details
- Status
- Prescription
- First Approved
- 1972-01-12
- Routes
- OPHTHALMIC
- Dosage Forms
- SUSPENSION/DROPS
FLUOROMETHOLONE Approval History
What FLUOROMETHOLONE Treats
2 indicationsFLUOROMETHOLONE is approved for 2 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation of the conjunctiva
- Inflammation of the cornea
FLUOROMETHOLONE 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.
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AMNEAL's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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.
FLUOROMETHOLONE FDA Label Details
Indications & Usage
Fluorometholone ophthalmic suspension 0.1% 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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FML FORTE
Full clinical data, patents, trials, and competitive landscape for fluorometholone.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.