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Data updated: Mar 10, 2026

ALREX

LOTEPREDNOL ETABONATE
Ophthalmology Approved 1998-03-09
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

Status
Prescription
First Approved
1998-03-09
Routes
OPHTHALMIC
Dosage Forms
SUSPENSION/DROPS

Companies

Active Ingredient: LOTEPREDNOL ETABONATE

ALREX Approval History

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What ALREX Treats

1 indications

ALREX is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Allergic Conjunctivitis
Source: FDA Label

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CHARTWELL RX
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Allergic Conjunctivitis
PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE
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COSETTE
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PROMETHAZINE PLAIN
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PHARMOBEDIENT
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Allergic Conjunctivitis
PROMETHEGAN
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Shared indications:
Allergic Conjunctivitis
ZERVIATE
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ZYLET
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Shared indications:
Allergic Conjunctivitis
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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.

ALREX FDA Label Details

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Indications & Usage

FDA Label (PDF)

ALREX ophthalmic suspension is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis.

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Data Sources

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