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Eskata FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 26, 2019.

FDA Approved: Yes (First approved December 14, 2017)
Brand name: Eskata
Generic name: hydrogen peroxide
Dosage form: Topical Solution
Company: Aclaris Therapeutics, Inc.
Treatment for: Keratosis

Eskata (hydrogen peroxide) 40% (w/w) topical solution is a high-concentration hydrogen peroxide formulation for the treatment of raised seborrheic keratoses.

Important Safety Information

  • Eskata is applied by your healthcare provider as an in-office treatment and is not for use at home.
  • Serious eye problems can happen if Eskata gets into your eyes. If Eskata accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes.
  • Skin reactions have occurred in and around the treatment area after application of Eskata. Reactions can be severe, including breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring.

The most common side effects of Eskata include itching, stinging, crusting, swelling, redness and scaling.

Development timeline for Eskata

Dec 17, 2017Approval Aclaris Therapeutics Receives FDA Approval for Eskata (hydrogen peroxide) Topical Solution, 40% (w/w) for the Treatment of Raised Seborrheic Keratoses
May  9, 2017FDA Accepts Aclaris Therapeutics’ New Drug Application for Topical Treatment of Seborrheic Keratosis, a Common Skin Condition
Feb 27, 2017Aclaris Therapeutics Submits New Drug Application for A-101 as a Novel Treatment for Seborrheic Keratosis – a Common Skin Condition

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.