Posted by Michael Wonder on 09 Jul 2020
CorMedix reports submission of Defencath new drug application
8 July 2020 - CorMedix today announced that all of the modules for the Defencath new drug application have been submitted to the FDA.
Defencath is being developed as a catheter lock solution with an initial indication for use of preventing catheter-related bloodstream infections in patients with end-stage renal disease who are receiving haemodialysis via a central venous catheter.
The application was granted rolling submission and review by FDA as announced previously, and there has been ongoing dialogue with FDA as it reviews the submitted modules.
