Posted by Michael Wonder on 28 Sep 2023
Botanix Pharmaceuticals suffers setback in FDA approval for sofpironium bromide gel to treat hyperhidrosis
26 September 2023 - Botanix Pharmaceuticals has had its application to use the novel sofpironium bromide gel to treat primary axillary hyperhidrosis rejected by the US FDA.
The clinical dermatology company received a comprehensive review from the FDA, which identified key issues centred around the instructions for using the gel, leading to a delay in its approval by 3-6 months.
