FDA confirms approach to Sofdra NDA resubmission and the materials required

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Clinical dermatology company Botanix Pharmaceuticals (ASX:BOT) has received feedback from the US FDA following its 'end of review' Type A meeting request with respect to the Sofdra new drug application review.

Botanix said the FDA confirmed that the planned content of materials proposed would be acceptable for the resubmission of the Sofdra NDA package, which is scheduled to be provided to the in early of the first quarter of 2024.

It said these materials are limited to the revised patient instructions for use, 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).

Botanix will also bring forward the annual safety update to the FDA, including the pharmacovigilance report from Japan and any new safety findings reported in the scientific literature.

Botanix CEO Dr Howie McKibbon said, “We are thankful to the Division for confirming the approach and materials proposed to be included in the resubmission of the NDA for Sofdra, which we are on track to file in early 1Q CY2024. The team will be working over the holiday break to ensure we complete the human factors study and assemble the materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”