Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistSarfez Pharmaceuticals distributed false and misleading promotional materials for SOAANZ® (torsemide), a loop diuretic used to treat edema in heart failure and renal disease patients, across two webpages, a healthcare provider pamphlet, and an exhibit booth panel presented at the American College of Cardiology conference in April 2024. The materials misrepresented both the drug's efficacy and safety profile despite the product carrying multiple contraindications and serious warnings, violations that were particularly concerning given the vulnerable elderly populations affected by these complex medical conditions. Additionally, Sarfez failed to submit these promotional materials to the FDA at the time of initial dissemination as required by regulations. The violations constitute misbranding under the Federal Food, Drug, and Cosmetic Act and render the materials' distribution unlawful.