Perrigo announced it has received tentative approval from the Food and Drug Administration (FDA) for Adapalene and Benzoyl Peroxide Gel, the generic version of Galderma‘s Epiduo Gel

Epiduo Gel is indicated for the treatment of acne vulgaris in patients aged ≥12 years. It combines adapalene, a retinoid, and benzoyl peroxide, an oxidizing agent. Adapalene binds to specific retinoic acid nuclear receptors and modulates cellular differentiation, keratinization and inflammatory processes. Benzoyl peroxide is known to exert bacteriocidal and keratolytic effects. 

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When granted final approval, Adapalene and Benzoyl Peroxide Gel will be available as a 0.1%/2.5% strength gel. 

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