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Arcutis Provides Update on sNDA for Roflumilast Cream 0.15% for Atopic Dermatitis
WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused
About this update from Arcutis Biotherapeutics, Inc.
[{"type":"text","content":"WESTLAKE VILLAGE, Calif., July 09, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the Company has been in communication with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for roflumilast cream 0.15% for the treatment of mild to moderate atopic dermatitis (AD) for adults and children down to the age of 6. The FDA has indicated that they are working to finalize the action letter and have not indicated they would extend the Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024. “We would like to emphasize that the FDA has not requested any additional information related to our sNDA. This speaks to the completeness and quality of our submission, as we have worked diligently to provide all necessary data and meet all regulatory requirements,” said Frank Watanabe, president and CEO of Arcutis. “We are in close contact with the FDA and anticipate receiving our action letter soon. Pending approval, we look forward to delivering this new innovative treatment in roflumilast cream to the millions suffering from atopic dermatitis.” About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio including two FDA approved products that harness our unique dermatology development platform coupled with our dermatology expertise to build differentiated therapies against biologically validated targets. Arcutis’ dermatology development platform includes a robust pipeline with multiple clinical programs for a range of inflammatory dermatological conditions including scalp and body psoriasis, atopic dermatitis, and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. Forward-Looking StatementsArcutis cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based...