Arcutis Biotherapeutics, Inc. 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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Jul. 09 | Arcutis Biotherapeutics Gets FDA Approval for Atopic Dermatitis Supplemental NDA | DJ |
Jul. 09 | Arcutis Biotherapeutics' Zoryve Gets US FDA Approval for Atopic Dermatitis | MT |
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- Arcutis Provides Update on sNDA for Roflumilast Cream 0.15% for Atopic Dermatitis