20 June 2024 - FDA approval was supported by results from the two pivotal Phase 3 studies evaluating the efficacy and safety of Sofdra in 701 patients with primary axillary hyperhidrosis.
Botanix Pharmaceuticals is pleased to announce the US FDA approval of Sofdra (sofpironium) gel, 12.45%. Sofdra is a prescription medicine used to treat primary axillary hyperhidrosis in adults and children 9 years and older.