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# Galderma Novel Topical OK’d for Acne
- URL: https://www.fdaweb.com/galderma-novel-topical-okd-for-acne/
- Published: 2019-10-07T12:00:00.000Z
- Updated: 2026-09-15T01:54:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145181

FDA has approved a Galderma NDA for Aklief (trifarotene) Cream, 0.005% for topically treating acne. Trifarotene, which is the first new retinoid molecule to receive FDA approval in more than 20 years, selectively targets retinoic acid receptor (RAR) gamma, according to the company. It is the first topical specifically studied to treat both facial and truncal (chest, shoulders and back) acne.

Approval is based on data from two pivotal Phase 3 parallel group, double-blind, vehicle-controlled clinical trials. The most common adverse reactions reported included application site irritation, itching and sunburn.