FLUOCINONIDE ACETONIDE (fluocinolone acetonide) · GLENMARK PHARMS LTD
FLUOCINONIDE ACETONIDE is FDA-approved to treat 2 conditions (same as ILUVIEN).
Details
- Status
- Discontinued
- First Approved
- 2018-10-26
- Routes
- TOPICAL, OTIC
- Dosage Forms
- OIL, OIL/DROPS
FLUOCINONIDE ACETONIDE Approval History
What FLUOCINONIDE ACETONIDE Treats
2 indicationsFLUOCINONIDE ACETONIDE is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetic Macular Edema
- Uveitis
Same approved indications as ILUVIEN (same active ingredient).
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.
FLUOCINONIDE ACETONIDE FDA Label Details
Indications & Usage
FLUOCINONIDE ACETONIDE is FDA-approved to treat 2 conditions — same approved indications as ILUVIEN.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.