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Data updated: Mar 10, 2026

LOTEPREDNOL ETABONATE

LOTEPREDNOL ETABONATE
Immunology Approved 2019-04-17
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
13
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-04-17
Routes
OPHTHALMIC
Dosage Forms
SUSPENSION/DROPS, GEL

Companies

SENTISS PADAGIS US Hikma Lupin AMNEAL Sun Pharma
Active Ingredient: LOTEPREDNOL ETABONATE

LOTEPREDNOL ETABONATE Approval History

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What LOTEPREDNOL ETABONATE Treats

9 indications

LOTEPREDNOL ETABONATE is approved for 9 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Inflammatory Conditions
  • Allergic Conjunctivitis
  • Superficial Punctate Keratitis
  • Herpes Zoster Keratitis
  • Iritis
  • Cyclitis
  • Infective Conjunctivitis
  • Anterior Uveitis
Source: FDA Label

Drugs Similar to LOTEPREDNOL ETABONATE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

MAXIDEX
DEXAMETHASONE
7 shared
HARROW EYE
Shared indications:
Inflammatory ConditionsAllergic ConjunctivitisSuperficial Punctate Keratitis +4 more
LOTEPREDNOL ETABONATE AND TOBRAMYCIN
LOTEPREDNOL ETABONATE
5 shared
ALEMBIC
Shared indications:
Allergic ConjunctivitisSuperficial Punctate KeratitisHerpes Zoster Keratitis +2 more
ZYLET
LOTEPREDNOL ETABONATE
5 shared
BAUSCH AND LOMB
Shared indications:
Allergic ConjunctivitisSuperficial Punctate KeratitisHerpes Zoster Keratitis +2 more
ACULAR
KETOROLAC TROMETHAMINE
1 shared
AbbVie
Shared indications:
Allergic Conjunctivitis
ALREX
LOTEPREDNOL ETABONATE
1 shared
BAUSCH AND LOMB
Shared indications:
Allergic Conjunctivitis
BEPOTASTINE BESILATE
BEPOTASTINE BESILATE
1 shared
SOMERSET THERAPS LLC
Shared indications:
Allergic Conjunctivitis
BEPREVE
BEPOTASTINE BESILATE
1 shared
BAUSCH AND LOMB INC
Shared indications:
Allergic Conjunctivitis
CARBINOXAMINE MALEATE
CARBINOXAMINE MALEATE
1 shared
MIKART
Shared indications:
Allergic Conjunctivitis
DEXTENZA
DEXAMETHASONE
1 shared
OCULAR THERAPEUTIX
Shared indications:
Allergic Conjunctivitis
KARBINAL ER
CARBINOXAMINE MALEATE
1 shared
AYTU
Shared indications:
Allergic Conjunctivitis
MAXITROL
DEXAMETHASONE
1 shared
HARROW EYE
Shared indications:
Infective Conjunctivitis
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
BACITRACIN ZINC
1 shared
BAUSCH AND LOMB
Shared indications:
Infective Conjunctivitis
PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE
1 shared
CHARTWELL RX
Shared indications:
Allergic Conjunctivitis
PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE
1 shared
COSETTE
Shared indications:
Allergic Conjunctivitis
PROMETHAZINE PLAIN
PROMETHAZINE HYDROCHLORIDE
1 shared
PHARMOBEDIENT
Shared indications:
Allergic Conjunctivitis
PROMETHEGAN
PROMETHAZINE HYDROCHLORIDE
1 shared
COSETTE
Shared indications:
Allergic Conjunctivitis
ZERVIATE
CETIRIZINE HYDROCHLORIDE
1 shared
HARROW EYE
Shared indications:
Allergic Conjunctivitis
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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.

LOTEPREDNOL ETABONATE FDA Label Details

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Indications & Usage

Loteprednol etabonate is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72%...

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Data Sources

FDA Approval: ANDA207609 → Label: DailyMed → Trials: ClinicalTrials.gov →

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