ALCAINE
Details
- Status
- Prescription
- First Approved
- 1971-12-22
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
ALCAINE Approval History
What ALCAINE Treats
1 indicationsALCAINE is approved for 1 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Corneal Anesthesia
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.
ALCAINE FDA Label Details
ProIndications & Usage
: ALCAINE™ ophthalmic solution is indicated for procedures in which a topical ophthalmic anesthetic is indicated: corneal anesthesia of short duration, e.g. tonometry, gonioscopy, removal of corneal foreign bodies, and for short corneal and conjunctival procedures.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.