MedPath

Tavaborole

Generic Name
Tavaborole
Brand Names
Kerydin
Drug Type
Small Molecule
Chemical Formula
C7H6BFO2
CAS Number
174671-46-6
Unique Ingredient Identifier
K124A4EUQ3

Overview

Tavaborale is a novel, boron-based topical antifungal medication for the treatment of onychomycosis, a fungal infection of the nail and nail bed due to Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole functions by inhibiting Leucyl-tRNA synthetase, or LeuRS, an essential fungal enzyme required for protein synthesis and for the catalysis of ATP-dependent ligation of L-leucine to tRNA(Leu).

Background

Tavaborale is a novel, boron-based topical antifungal medication for the treatment of onychomycosis, a fungal infection of the nail and nail bed due to Trichophyton rubrum or Trichophyton mentagrophytes infection. Tavaborole functions by inhibiting Leucyl-tRNA synthetase, or LeuRS, an essential fungal enzyme required for protein synthesis and for the catalysis of ATP-dependent ligation of L-leucine to tRNA(Leu).

Indication

Indicated for the treatment of onychomycosis (a fungal infection) of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes.

Associated Conditions

  • Onychomycosis of the Toenails caused by Trichophyton mentagrophytes
  • Onychomycosis of the Toenails caused by Trichophyton rubrum

FDA Approved Products

Product Name
Manufacturer
Route
Strength
Approved
NDC Code
Tavaborole
Chartwell RX, LLC
TOPICAL
43.5 mg in 1 mL
2023/09/15
62135-663
TAVABOROLE
Cipla USA Inc.
TOPICAL
43.5 mg in 1 mL
2024/01/09
69097-686
Tavaborole
Padagis US LLC
TOPICAL
43.5 mg in 1 mL
2021/01/11
0574-0157
Tavaborole
Amneal Pharmaceuticals NY LLC
TOPICAL
43.5 mg in 1 mL
2019/06/15
69238-1657
TAVABOROLE
Aleor Dermaceuticals Limited
TOPICAL
43.5 mg in 1 mL
2021/12/01
71589-010
Tavaborole
Bryant Ranch Prepack
TOPICAL
43.5 mg in 1 mL
2022/02/23
63629-8704
Tavaborole
Alembic Pharmaceuticals Inc.
TOPICAL
43.5 mg in 1 mL
2023/12/15
62332-467
TAVABOROLE
Taro Pharmaceuticals U.S.A., Inc.
TOPICAL
43.5 mg in 1 mL
2019/05/28
51672-1397
Tavaborole
Zydus Lifesciences Limited
TOPICAL
43.5 mg in 1 mL
2023/04/12
70771-1826
Tavaborole
Encube Ethicals Private Limited
TOPICAL
43.5 mg in 1 mL
2020/10/29
21922-020

EMA Approved Products

Medicine Name
EMA Number
Auth. Holder
Country
Drug Type
Status
Issued
Opinion
Revision

No EMA products found

No EMA products found for this drug

Singapore Approved Products

Product Name
Manufacturer
Dosage Form
Strength
Approved
Approval No.
Online

No Singapore products found

No Singapore products found for this drug

China Approved Products

Product Name
Approval No.
Manufacturer
Dosage Form
Trade Name
Strength
Type
Status
Date
Import

No China products found

No China products found for this drug

Australia Approved Products

Product Name
ARTG ID
Sponsor
Status
Reg. Date
Ingredient

No Australia products found

No Australia products found for this drug

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