Arcutis Expects FDA's Action Letter For Roflumilast SNDA Indicated For Atopic Dermatitis

(RTTNews) - Arcutis Biotherapeutics, Inc. (ARQT) Tuesday revealed that the FDA has been working to finalize the action letter on its supplemental New Drug Application or sNDA) for roflumilast cream 0.15% for atopic dermatitis. In its communication, the regulator has not indicated about an extention of the Prescription Drug User Fee Act goal date of July 7, 2024.

The commercial-stage biopharmaceutical company said, Roflumilast cream is indicated for the treatment of mild to moderate atopic dermatitis for adults and children down to the age of 6.

Frank Watanabe, president and CEO of Arcutis said, "We would like to emphasize that the FDA has not requested any additional information related to our sNDA. We are in close contact with the FDA and anticipate receiving our action letter soon.