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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  […]