CorMedix Receives Second Complete Response Letter for DefenCath NDA

The FDA has rejected for the second time a New Drug Application (NDA) by CorMedix for DefenCath (taurolidine/citrate/heparin) for preventing bloodstream infections in patients with renal failure who are receiving hemodialysis via a central venous catheter.

CorMedix received the first Complete Response Letter (CRL) in 2021, which cited concerns about a third-party manufacturing facility after the FDA reviewed records provided by the manufacturing facility.

In its second CRL, the agency said it observed deficiencies related to the contract manufacturing organization and the supplier of the drug’s active pharmaceutical ingredient heparin.

The company plans on continuing to pursue the investigational drug’s approval.