TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

AKTEN

LIDOCAINE HYDROCHLORIDE
Approved 2008-10-07
1
Indication
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-10-07
Routes
OPHTHALMIC
Dosage Forms
GEL

Companies

Active Ingredient: LIDOCAINE HYDROCHLORIDE

AKTEN Approval History

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What AKTEN Treats

1 FDA approvals

Originally approved for its first indication in 2008 .

  • Other (1)
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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.

AKTEN FDA Label Details

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AKTEN Patents & Exclusivity

Latest Patent: Jul 2026

Patents (1 active)

US8759401 Expires Jul 24, 2026
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.