TheraRadar
Data updated: May 26, 2026

KERYDIN (tavaborole)

Infectious Disease Approved 2014-07-07
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
11
Years on Market

Details

Status
Discontinued
First Approved
2014-07-07
Routes
TOPICAL
Dosage Forms
SOLUTION

Companies

ANACOR PHARMS INC
Active Ingredient: TAVABOROLE

KERYDIN Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2014 to 2018 · 1 indication expansions
Jul 2018 SUPPL Priority
Efficacy
FDA Letter Label
Dec 2015 SUPPL
Mfg · Manufacturing (CMC)
Jun 2015 SUPPL
Mfg · Manufacturing (CMC)

What KERYDIN Treats

2 FDA approvals

Originally approved for its first indication in 2014 . Covers 2 distinct patient populations.

  • Other (2)
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Active Pipeline

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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.

KERYDIN FDA Label Details

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Data Sources

FDA Approval: NDA204427 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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