TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

OTOVEL

CIPROFLOXACIN HYDROCHLORIDE
Infectious Disease Approved 2016-04-29
1
Indication
--
Phase 3 Trials
9
Years on Market

Details

Status
Prescription
First Approved
2016-04-29
Routes
OTIC
Dosage Forms
SOLUTION/DROPS

OTOVEL Approval History

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What OTOVEL Treats

1 indications

OTOVEL is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bacterial Conjunctivitis
Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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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

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.

OTOVEL FDA Label Details

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Indications & Usage

FDA Label (PDF)

: CILOXAN ® (ciprofloxacin ophthalmic ointment) 0.3% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the microorganisms listed below: Gram-Positive: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus Viridans Group Gram-Negative: Haemophilus influenzae

OTOVEL Patents & Exclusivity

Latest Patent: Mar 2030

Patents (1 active)

US8932610 Expires Mar 24, 2030
Source: FDA Orange Book

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Data Sources

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