GATIFLOXACIN · Lupin
Gatifloxacin is an eye drop used for patients with bacterial conjunctivitis. It helps patients with eye infections caused by specific susceptible bacteria, including various strains of Staphylococcus and Streptococcus. This medication treats the underlying bacterial cause to help resolve the condition.
How GATIFLOXACIN Works
Gatifloxacin works by acting as a quinolone antimicrobial. It targets specific aerobic gram-positive and gram-negative bacteria to clear the infection.
Details
- Status
- Prescription
- First Approved
- 2003-03-28
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS, SOLUTION
GATIFLOXACIN Approval History
What GATIFLOXACIN Treats
1 indicationsGATIFLOXACIN is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bacterial Conjunctivitis
GATIFLOXACIN 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.
Drugs Similar to GATIFLOXACIN
3 of 7FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00410891 results posted | 96803 (eProtocol 4384) | Ph 4 | completed | Topical Antibiotics and Intravitreous Injections |
| NCT01421693 | 03NP | Ph 4 | completed | Gatifloxacin Versus Ceftriaxone in the Treatment of Enteric Fever |
| NCT01330355 results posted | 646 | Ph 3 | terminated | Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis |
| NCT00824070 results posted | 575 | Ph 1 | completed | Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects |
| NCT00905762 | 608 | Ph 1 | completed | Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation |
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.
GATIFLOXACIN FDA Label Details
Indications & Usage
Gatifloxacin ophthalmic solution 0.5 % is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group * Streptococcus oralis* Streptococcus pneumoniae Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution 0.5 % is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the ...
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Full clinical data, patents, trials, and competitive landscape for gatifloxacin.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.