Botanix Pharmaceuticals Limited announced that the Company has received feedback from FDA following its "end of review" Type A meeting request in respect to the Sofpironium Bromide gel, 15% ("SofdraTM") new drug application ("NDA") review that was completed in September 2023. FDA confirmed that the planned content of materials proposed by Botanix would be acceptable for the resubmission of the Sofdra NDA package which is scheduled to be provided to FDA in early first quarter current year 2024. These materials are limited to the revised patient instructions for use ("IFU"); the new human factors validation study protocol and report; an updated use-related risk analysis and updated draft prescribing information, carton, and container labels; and the proposed proprietary name (Sofdra) submission.

Botanix will also bring forward the annual safety update to FDA including the pharmacovigilance report from Japan and any new safety findings reported in the scientific literature (which would otherwise usually be filed in March each year). All of these materials are either prepared or will be finalized in preparation for the planned resubmission in early first quarter current year 2024.