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Eskata Approval History

  • FDA approved: Yes (First approved December 14th, 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 History and FDA Approval Process for Eskata

DateArticle
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
Nov 15, 2016Aclaris Therapeutics Announces Positive Top-Line Phase 3 Results for A-101 In Treating Seborrheic Keratosis, a Common Undertreated Skin Condition

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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