TheraRadar
Data updated: Jul 17, 2026

FLUOCINOLONE ACETONIDE · ALPHARMA US PHARMS

Generic · see YUTIQ
Dermatology Approved 1963-02-15

FLUOCINOLONE ACETONIDE is FDA-approved to treat 2 conditions (same as ILUVIEN).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
29
Indications
--
Phase 3 Trials
63
Years on Market

Details

Status
Prescription
First Approved
1963-02-15
Routes
TOPICAL, OTIC
Dosage Forms
CREAM, SOLUTION, OIL, OIL/DROPS, OINTMENT

Companies

ALPHARMA US PHARMS SUN PHARMA CANADA FOUGERA PHARMS AMNEAL Lupin QUAGEN BAUSCH AND LOMB INC PADAGIS ISRAEL NOVEL LABS INC Teva CHARTWELL RX PERRIGO NEW YORK ALLIED USL PHARMA COSETTE PHARMS NC PAI HOLDINGS RISING GLENMARK PHARMS LTD PHARMAFAIR SCIEGEN PHARMS INVATECH TP ANDA HOLDINGS ENCUBE ETHICALS PHARMADERM
Active Ingredient: FLUOCINOLONE ACETONIDE

FLUOCINOLONE ACETONIDE Approval History

1983
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2026
Original
New Indication
New Form
Label Update
126 FDA actions from 1982 to 2026
Jun 2026 SUPPL
Label · Labeling
Oct 2025 SUPPL
Label · Labeling
Sep 2025 SUPPL
Label · Labeling

What FLUOCINOLONE ACETONIDE Treats

2 indications

FLUOCINOLONE ACETONIDE is approved for 2 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as ILUVIEN (same active ingredient).

Source: FDA Label
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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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

FLUOCINOLONE ACETONIDE FDA Label Details

Indications & Usage

FLUOCINOLONE ACETONIDE is FDA-approved to treat 2 conditions — same approved indications as ILUVIEN.

Looking for the branded version?

YUTIQ

Full clinical data, patents, trials, and competitive landscape for fluocinolone acetonide.

See YUTIQ

Data Sources

FDA Approval: ANDA088361 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.