The company is focused on developing its lead product DefenCath, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis. DefenCath has received US Food and Drug Administration (FDA) Fast Track designation and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need.
DefenCath was approved by the FDA on November 15, 2023 and the company has indicated an estimated initial launch in the first quarter of 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the company is working to develop taurolidine-based therapies for rare pediatric cancers.
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