Posted by Michael Wonder on 22 Jan 2024
Botannix Pharmaceuticals’ resubmission of Sofdra NDA accepted by FDA
22 January 2024 - Botannix Pharmaceuticals’ resubmission of the new drug application for Sofdra has been accepted by the FDA as a complete response.
The resubmission focused on the instructions for use, with no other efficacy, safety, pharmacology, non-clinical or chemistry, or other manufacturing and control issues identified.
