Pharma Focus Europe

Cormedix Inc. Receives FDA Acceptance for Resubmitted New Drug Application for Defencath

Thursday, June 22, 2023

CorMedix Inc., listed on Nasdaq as CRMD, is a biopharmaceutical company that focuses on the development and commercialization of therapeutic products for the treatment and prevention of life-threatening diseases and conditions. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for their product DefenCath. The FDA has classified the resubmission as a complete, Class 2 response, and has set a target action date of November 15, 2023, under the Prescription Drug User Fee Act (PDUFA).

DefenCath is being developed as a catheter lock solution for reducing catheter-related bloodstream infections (CRBSIs) in patients with kidney failure who receive chronic hemodialysis through a central venous catheter.

CorMedix's Chief Executive Officer, Joe Todisco, expressed the company's appreciation for the acceptance of the DefenCath NDA resubmission, considering it an important milestone in their efforts to minimize the risks associated with hemodialysis via central venous catheters. Todisco acknowledged the hard work of the CorMedix team and their strategic partners and mentioned that the company will provide additional updates in the coming months as they prepare for a potential commercial launch.

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