TheraRadar
Data updated: May 26, 2026

ALCAFTADINE

Ophthalmology Approved 2023-06-23
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
Discontinued
First Approved
2023-06-23
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

EUGIA PHARMA ALEMBIC GLAND
Active Ingredient: ALCAFTADINE

ALCAFTADINE Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2023 to 2024
Oct 2024 ORIGINAL
Update
Mar 2024 ORIGINAL
Update
Jun 2023 ORIGINAL
Update
FDA Letter

What ALCAFTADINE Treats

3 FDA approvals

Originally approved for its first indication in 2023 . Covers 3 distinct patient populations.

  • Other (3)
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00889330 results posted 09-003-05 Ph 3 completed Safety and Efficacy Study of a Eye Drop for Eye Allergy
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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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.

ALCAFTADINE FDA Label Details

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LASTACAFT

Full clinical data, patents, trials, and competitive landscape for alcaftadine.

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Data Sources

FDA Approval: ANDA210659 → Trials: ClinicalTrials.gov →

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