Botanix Pharmaceuticals has announced that the Company has successfully completed the planned human factors validation study assessing revised Instructions for Use (IFU) for Sofdra™.
All HF Study participants successfully prepared and applied Sofdra in accordance with the revised IFU, and both users and caregivers successfully completed the use-related tasks.
Botanix CEO, Dr Howie McKibbon, said:
“We are very pleased with the outcome of the HF Study for Sofdra and the performance of the revised IFU in guiding patients to the safe and successful use of the product.
“The team will continue working over the holiday break to expeditiously assemble materials for resubmission to allow a rapid turnaround and filing with FDA for Sofdra approval.”
Botanix will now prepare to resubmit the Sofdra new drug application to FDA in 1Q CY2024, targeting FDA approval in mid-CY2024.