OFLOXACIN · CADILA PHARMS LTD
Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli , Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa and Staphylococcus aureus.
Details
- Status
- Prescription
- First Approved
- 1990-12-28
- Routes
- ORAL, OTIC, OPHTHALMIC, INJECTION
- Dosage Forms
- TABLET, SOLUTION/DROPS, INJECTABLE
Companies
OFLOXACIN Approval History
What OFLOXACIN Treats
3 indicationsOFLOXACIN is approved for 3 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Otitis Externa
- Chronic Suppurative Otitis Media
- Acute Otitis Media
OFLOXACIN 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 OFLOXACIN
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03933631 PAACK | 2018-9829 | Ph 3 | recruiting | Pilocarpine Use After Kahook Goniotomy |
| NCT05302531 GRAAL | 2021-001468-13 | Ph 1 | recruiting | Absorption of Antibiotics With High Oral Bioavailability in Short-bowel Syndrome |
| NCT04005079 PACCT | 2017-8704 | Ph 3 | withdrawn | Pilocarpine After Combined Cataract/Trabectome Surgery |
| NCT04353362 | Istanbul Medipol | Ph 4 | completed | Alternative Antibiotic Regimen in Periodontitis Treatment |
| NCT01799356 | Asicioglu03 treatment, treatment uPID | Ph 4 | completed | Moxifloxacin Versus Ofloxacin Plus Metronidazole in Uncomplicated Pelvic Inflammatory Disease: Multicenter Randomized Controlled Trials |
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.
OFLOXACIN FDA Label Details
Indications & Usage
FDA Label (PDF)Ofloxacin Otic Solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli , Pseudomonas aeruginosa and Staphylococcus aureus. Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis , Pseudomonas aeruginosa and Staphylococcus aureus. Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophil...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.