Arcutis Provides Update On sNDA for Roflumilast Cream 0.15%, Says FDA Has Indicated That They Are Working To Finalize The Action Letter And Have Not Indicated They Would Extend The PDUFA Goal Date Of July 7, 2024

Author: Benzinga Newsdesk | July 09, 2024 08:33am

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.

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