Journey Medical Corporation Announces Successful Completion of Pre-NDA Meeting with the FDA for DFD-29 to Treat Rosacea
DFD-29 is being developed in collaboration with Dr. Reddy’s Laboratories Ltd.
- 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.
- The Phase 3 clinical trials achieved all co-primary and secondary endpoints and subjects completed the 16-week treatment with no significant safety issues.