U.S. FDA Accepts Supplemental New Drug Application for Arcutis' ZORYVE® (roflumilast) Cream 0.05% for the Treatment of Children Aged 2 to 5 with Mild to Moderate Atopic Dermatitis
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The FDA has accepted Arcutis Biotherapeutics' supplemental New Drug Application for ZORYVE cream 0.05% to treat children aged 2 to 5 with mild to moderate atopic dermatitis. The decision is expected by October 13, 2025, and is backed by positive trial data.
February 26, 2025 | 1:15 pm
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Arcutis Biotherapeutics' ZORYVE cream sNDA has been accepted by the FDA for treating atopic dermatitis in young children, with a decision expected by October 2025. This could expand their market reach significantly.
The FDA's acceptance of the sNDA is a positive regulatory step for Arcutis, potentially leading to an expanded market for ZORYVE cream. The decision date is set for October 2025, and if approved, it could significantly increase the company's market presence in treating atopic dermatitis in young children.
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