FDA Agrees to DefenCath Study from CRL

At a meeting with CorMedix and its DefenCath (taurolidine/heparin catheter lock solution) third-party manufacturer, FDA and the firm agreed to a protocol for a manual extraction study identified in a complete response letter the agency had issued. The agency is requiring the study as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials.

CorMedix says it expects to be able to complete this requirement in the next several weeks.

Addressing FDA concerns that the qualification of the filling operation may require adjustments in the process and generation of additional data on operating parameters for manufacturing of DefenCath, CorMedix says it and its third-party manufacturer are evaluating available data to determine if additional process qualification will be needed with subsequent validation to address the issues.

FDA told the company the review timeline would be determined when the NDA resubmission is received.