The FDA has approved Zoryve (roflumilast) cream 0.15% for the treatment of mild to moderate atopic dermatitis in both adult and pediatric patients aged 6 years and older. This approval was based on positive results from three phase 3 studies, a phase 2 study, and two phase 1 studies. Zoryve is a steroid-free, once-daily topical phosphodiesterase 4 (PDE4) inhibitor that has previously been approved for plaque psoriasis and seborrheic dermatitis. The cream will be available as a new treatment option for atopic dermatitis patients by the end of July through key wholesaler and dermatology pharmacy channels.
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FDA approves Zoryve for atopic dermatitis in adults, children
