Journey Medical announces completion of pre-NDA meeting with FDA for DFD-29

Journey Medical announced that the Company received the official meeting minutes from its pre-New Drug Application, NDA, meeting with the FDA for DFD-29 to treat rosacea in adults. DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd. The purpose of the meeting was to discuss the 505(b)(2) NDA submission plan for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea. During the pre-NDA meeting and in the official meeting minutes,the FDA agreed that the proposed data package is sufficient to support the NDA submission, which the Company continues to anticipate will occur around year-end of 2023. “We are encouraged by the pre-NDA meeting and the progress we have made towards our goal of securing the regulatory review and approval necessary to make DFD-29 available to patients. With all of the unique differentiators DFD-29 brings to the patient, it has the potential to become the best-in-class and the only oral, systemic therapy to address both inflammatory lesions and redness from rosacea, changing the treatment paradigm for this long-term inflammatory skin condition,” said Claude Maraoui, Co-Founder, President and Chief Executive Officer of Journey Medical.