Posted by Michael Wonder on 01 Mar 2021
CorMedix receives complete response letter from FDA for DefenCath catheter lock solution
1 March 2021 - CorMedix announced today that the US FDA cannot approve the new drug application for DefenCath (taurolidine/heparin catheter lock solution) in its present form.
FDA noted concerns at the third-party manufacturing facility after a review of records requested by FDA and provided by the manufacturing facility.
The 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.
