Posted by Michael Wonder on 02 Mar 2022
Cormedix announces resubmission of new drug application for Defencath
28 February 2022 - CorMedix today announced that it has resubmitted the new drug application for DefenCath to address the complete response letter issued by the U.S. FDA a year ago.
In parallel, the Company’s third-party manufacturer submitted responses to the deficiencies identified at the manufacturing facility in the Post-Application Action Letter issued by the FDA concurrently with the complete response letter.
DefenCath is being developed as a catheter lock solution with an initial indication of use for the reduction of catheter-related bloodstream infections in patients with renal failure who are receiving chronic haemodialysis via a central venous catheter.
