FDA Accepts Application to Expand Atopic Dermatitis Treatment for Infants as Young as 3 Months

The FDA has accepted a supplemental New Drug Application (sNDA) for roflumilast cream 0.05% (Zoryve) to treat mild to moderate atopic dermatitis in infants aged 3 months to younger than 2 years. This regulatory step could significantly expand treatment options for a very young patient population.