Journey Medical Successful Completion of Pre-NDA Meeting for Rosacea Therapy

 Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical” or “the Company”), a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the Company received the official meeting minutes from its pre-New Drug Application (“NDA”) meeting with the FDA for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) 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 (papules and pustules) 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.

https://www.globenewswire.com/news-release/2023/12/06/2791735/0/en/Journey-Medical-Corporation-Announces-Successful-Completion-of-Pre-NDA-Meeting-with-the-FDA-for-DFD-29-to-Treat-Rosacea.html