FDA Approves Sofpironium Gel for Primary Axillary Hyperhidrosis
The U.S. Food and Drug Administration has approved sofpironium topical gel, 12.45% (Sofdra, Botanix) for primary axillary hyperhidrosis in adults and children aged nine and older. The FDA approval was supported by results from the two pivotal Phase 3 ‘CARDIGAN’ studies which evaluated the efficacy and safety of Sofdra versus vehicle and enrolled 701 patients […]