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# FDA Issues Complete Response on CorMedix DefenCath
- URL: https://www.fdaweb.com/fda-issues-complete-response-on-cormedix-defencath/
- Published: 2021-03-01T12:00:00.000Z
- Updated: 2026-09-14T16:48:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148769

FDA has issued CorMedix a complete response letter on its NDA for DefenCath (taurolidine/heparin catheter lock solution) for use in kidney failure patients receiving chronic hemodialysis through a central venous catheter. The agency letter cited concerns at a third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility, the company says. “FDA did not specify the issues and CorMedix intends to work with the manufacturing facility to develop a plan for resolution when FDA informs the facility of the specific concerns,” it says.

Additionally, FDA’s letter requested a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications, CorMedix says. “Satisfactory resolution of these issues is required for approval of the DefenCath NDA by a pre-approval inspection and/or adequate manufacturing facility responses addressing these concerns,” it says, adding that if an inspection is required, there is a current backlog due to the Covid-19 pandemic that will further delay approval. It also notes FDA did not request additional clinical data, and did not identify any deficiencies related to the data submitted on Defencath’s efficacy or safety.