India, July 8 -- Arcutis Biotherapeutics Inc. (ARQT), a commercial-stage biopharmaceutical company focused on immuno-dermatology, announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for ZORYVE (roflumilast) cream 0.05%.
The application seeks to expand the indication for the topical treatment of mild to moderate atopic dermatitis to include infants aged 3 to 24 months.
Atopic dermatitis, commonly known as eczema, is a chronic inflammatory skin condition that causes redness, itching, and irritation. It often begins in infancy and can significantly affect sleep and quality of life for both children and caregivers.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target...