TheraRadar
Data updated: Jun 28, 2026

FLO-PRED (prednisolone acetate) · SUN PHARMA CANADA

Ophthalmology Approved 2008-01-17

FLO-PRED is FDA-approved to treat 4 conditions (same as PRED MILD).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
18
Years on Market

Details

Status
Discontinued
First Approved
2008-01-17
Patent Cliff
2028

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Routes
ORAL
Dosage Forms
SUSPENSION

Companies

SUN PHARMA CANADA
Active Ingredient: PREDNISOLONE ACETATE

FLO-PRED Approval History

2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
20 FDA actions from 2008 to 2024
Jun 2024 SUPPL
Label · Labeling
FDA Letter Label
Jul 2021 SUPPL
Label · Labeling
FDA Letter Label
Oct 2014 SUPPL
Mfg · Manufacturing (CMC)

What FLO-PRED Treats

4 indications

FLO-PRED is approved for 4 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Allergic Disorder
  • Inflammatory Disorder
  • Chemical Burn
  • Thermal Burn

Same approved indications as PRED MILD (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

13 trials
Trial Sponsor ID Phase Status Title
NCT04351737 PERSIST PERSIST Study Ph 4 completed Dextenza for Post-operative Treatment of Pterygium
NCT06679153 VVN461-CCS-201 Ph 2 completed A Phase 2 Study of VVN461 Ophthalmic Solution for Noninfectious Anterior Uveitis
NCT04168112 results posted LINK1 Ph 4 completed Intracanalicular Dexamethasone Insert for Post-Corneal Cross-Linking Inflammation and Pain- The LINK Study
NCT04464629 The FINNEN Study Ph 4 terminated Assessing the Efficacy and Safety of DEXTENZA in Pseudo Phakic Patients Undergoing Gas Bubble Repair and Laser Following Retinal Detachment
NCT04563299 DETeR DETeR Ph 4 terminated Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections
NCT01939691 MEND 18-24978 Ph 4 terminated Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
NCT04273282 1909 D3 EyePoint Ph 4 completed A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%
NCT03596723 results posted KPI-121-C-010 Ph 3 terminated KPI-121 1% Versus Prednisolone for the Treatment of Inflammation Following Cataract Surgery in Children
NCT01853072 results posted C-12-067 Ph 3 completed Nepafenac Once Daily for Macular Edema - Study 1
NCT01872611 results posted C-12-071 2013-001874-12 Ph 3 completed Nepafenac Once Daily for Macular Edema - Study 2
NCT01482897 Hiatus BRD 11/4-M Ph 3 terminated Efficacy of corticoïd Infiltration Via Sacro-coccygien Hiatus in Discal Sciatica
NCT01448213 results posted 2011-0329 Ph 2 completed Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)
NCT00758199 2008-0036 Ph 4 completed Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery
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Active Pipeline

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Key Completed Trials

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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.

FLO-PRED FDA Label Details

Indications & Usage

FDA Label (PDF)

FLO-PRED is FDA-approved to treat 4 conditions — same approved indications as PRED MILD.

View full patent landscape →
1 OB patents · 1 families · 22 international docs across 11 countries

FLO-PRED Patents & Exclusivity

Latest Patent: Oct 2028

Patents (1 active)

US7799331 Expires Oct 11, 2028
Source: FDA Orange Book

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Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2028
  • • 8 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA022067 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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