Botanix Pharmaceuticals has announced that the Company has successfully completed resubmission of the new drug application (NDA) for Sofdra™. FDA approval for Sofdra is now targeted for late 2Q 2024.
The NDA resubmission follows successful completion of the human factors validation study that assessed revised Instructions for Use (IFU) for Sofdra.
Botanix CEO, Dr Howie McKibbon, said:
“We are pleased to advise that the resubmission of the Sofdra NDA has been completed well ahead of schedule, and I am very appreciative of the effort the Botanix team has exerted over the last few months to achieve this earlier than expected filing.
“Our focus now is firmly on preparation for commercialisation as we work with FDA towards Sofdra approval by midyear.”