Arcutis Submits Supplemental New Drug Application to the FDA for ZORYVE® (roflumilast) Cream 0.05% to Expand Indication for Treatment of Atopic Dermatitis to Infants Down to 3 Months
Arcutis Biotherapeutics has submitted a supplemental New Drug Application to the FDA seeking approval to expand the indication of its topical therapy ZORYVE® (roflumilast) cream 0.05% to treat mild to moderate atopic dermatitis in infants aged 3 months to less than 24 months. This submission is supported by positive Phase 1 and Phase 2 clinical tri…