The FDA (Food and Drug Administration - US) has conducted the mid-cycle review meeting for Sofpironium Bromide, Botanix Pharmaceuticals' (ASX:BOT) lead product which helps with excessive sweating.
Botanix Pharmaceuticals says no significant issues have been identified by the FDA as a result of their review, and also noted no major clinical safety issues, risk management issues, or advisory board requirements.
The company also says FDA-indicated future discussions will focus on labeling, clinical outcome assessments, patient instructions, and brand name.
The planned approval date for Sofpironium Bromide in September 2023 remains on track.