Is arqt awaiting fda apprpvap

Arcutis' FDA approval for ZORYVE® (roflumilast) Cream 0.15% has been anticipated. The FDA approval was granted on July 9, 2024, for the treatment of atopic dermatitis in adults and children down to 6 years of age. This follows the acceptance of Arcutis' supplemental new drug application (sNDA) in November 2023, and the company had previously provided an update on the delayed status of the FDA’s approval, indicating that the Prescription Drug User Fee Act (PDUFA) goal date of July 7, 2024, would not be extended. The FDA's decision was based on positive safety and efficacy data from three Phase 3 programs, including the INTEGUMENT-1 and INTEGUMENT-2 trials.