BROMFENAC SODIUM · AMRING PHARMS
Bromfenac sodium is an eye drop used for patients who have recently undergone cataract surgery. It helps manage postoperative inflammation and reduces eye pain that can occur after the procedure. This medication is typically prescribed to support recovery and improve patient comfort during the healing process following surgery.
How BROMFENAC SODIUM Works
This medication works by inhibiting the cyclooxygenase (COX) 1 and 2 enzymes, which blocks the synthesis of prostaglandins. By reducing these inflammatory mediators, the drug helps prevent vasodilation, increased vascular permeability, and elevated intraocular pressure in the eye.
Details
- Status
- Prescription
- First Approved
- 2005-03-24
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
Companies
BROMFENAC SODIUM Approval History
What BROMFENAC SODIUM Treats
2 indicationsBROMFENAC SODIUM is approved for 2 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Inflammation
- Ocular Pain
BROMFENAC SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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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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.
BROMFENAC SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)Bromfenac ophthalmic solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac ophthalmic solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.
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PROLENSA
Full clinical data, patents, trials, and competitive landscape for bromfenac sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.