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# FDA Approves CorMedix’s Defencath
- URL: https://www.fdaweb.com/fda-approves-cormedixs-defencath/
- Published: 2023-11-15T12:00:00.000Z
- Updated: 2026-09-14T14:16:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155797

FDA has approved CorMedix’s Defencath (taurolidine and heparin) catheter lock drug to reduce catheter-related bloodstream infections in adult patients with kidney failure who are receiving chronic hemodialysis through a central venous catheter. The agency says it is the third drug approved under the [Limited Population Pathway for Antibacterial and Antifungal Drugs](https://www.fda.gov/drugs/development-resources/limited-population-pathway-antibacterial-and-antifungal-drugs-lpad-pathway?ref=fdaweb.com).

Approval was based on data from a single Phase 3 trial that demonstrated Defencath delayed the time it took to acquire a catheter-related bloodstream infection (CRBSI), an [agency release](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&cad=rja&uact=8&ved=2ahUKEwi16qu43MaCAxWKkIkEHZulBlEQFnoECBEQAQ&url=https%3A%2F%2Fwww.fda.gov%2Fdrugs%2Fnews-events-human-drugs%2Ffda-approves-new-drug-under-special-pathway-patients-receiving-hemodialysis&usg=AOvVaw1Ayx0O74uxuN-oTieensIG&opi=89978449) says. “Defencath demonstrated a 71% risk reduction in CRBSIs versus the heparin comparator arm (95% confidence interval for risk reduction: 38% to 86%; p value = 0.0006),” it says.

Regarding safety, FDA says Defencath has warnings for Heparin-Induced Thrombocytopenia (HIT) and drug hypersensitivity reactions. In the clinical trial, the most frequently reported adverse reactions were “hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia,” it adds.