FLAC (fluocinolone acetonide)
FLAC is indicated for the treatment of Dermatoses.
Details
- Status
- Prescription
- First Approved
- 2018-04-11
- Routes
- OTIC
- Dosage Forms
- OIL/DROPS
FLAC Approval History
What FLAC Treats
1 indicationsFLAC is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dermatoses
FLAC 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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Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05844982 AL | Protocol AL UG1EY014231 | Ph 3 | recruiting | Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy |
| NCT01781936 Iluvien | Pro00033019 | Ph 1 | completed | Pilot Study of a Fluocinolone Acetonide Intravitreal Insert (FA-i) to Treat Intermediate-, Posterior-, or Panuveitis |
| NCT00695318 results posted | C-01-08-004 | Ph 2 | terminated | Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy |
| NCT00770770 FAVOR results posted | C-01-08-006 | Ph 2 | terminated | Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina |
| NCT01304706 results posted | C-01-11-008 | Ph 3 | completed | Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study |
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.
FLAC FDA Label Details
Indications & Usage
FLAC is indicated for the treatment of Dermatoses.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.