Kerydin

NDA 204427, held by Anacor Pharms Inc. Tavaborole.

As of Nov 14, 2026, NDA 204427 (Kerydin), held by Anacor Pharms Inc, was first approved by FDA on Jul 7, 2014, with 6 approved supplements and 0 published complete response letters.

First approved: Jul 7, 2014
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Jul 30, 2018	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Jul 7, 2014	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Kerydin5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution;topical	Tavaborole	DiscontinuedReference drug

All 7 submissions, including labeling and manufacturing supplements


Jul 30, 2018	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label Pediatric Medical Review
Dec 14, 2015	Supplement 5Manufacturing · Standard review	Approved	None posted
Jun 26, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 27, 2015	Supplement 3Labeling · Standard review	Approved	Label Letter
Jan 20, 2015	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 15, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Jul 7, 2014	Original applicationNew molecular entity · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 204427
Drugs@FDA: Overview at FDA
Company: Anacor Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters