FX.co ★ Arcutis Expects FDA's Action Letter For Roflumilast SNDA Indicated For Atopic Dermatitis

Arcutis Biotherapeutics, Inc. (ARQT) announced on Tuesday that the FDA is in the final stages of preparing the action letter for its supplemental New Drug Application (sNDA) for roflumilast cream 0.15%, intended for the treatment of atopic dermatitis. The FDA has not indicated any extension of the Prescription Drug User Fee Act (PDUFA) goal date, which remains set for July 7, 2024.

The company highlighted that roflumilast cream is designed to treat mild to moderate atopic dermatitis in both adults and children aged six and older.

Frank Watanabe, President and CEO of Arcutis, stated, "We would like to emphasize that the FDA has not requested any additional information regarding our sNDA. We are maintaining close communication with the FDA and anticipate receiving our action letter in the near future."