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Cormedix Inc. Announces Resubmission of New Drug Application for DefenCath
BERKELEY HEIGHTS, N.J., Feb. 28, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
About this update from Cormedix Inc.
[{"type":"text","content":"BERKELEY HEIGHTS, N.J., Feb. 28, 2022 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that it has resubmitted the New Drug Application (NDA) for DefenCath to address the Complete Response Letter (CRL) issued by the U.S. Food and Drug Administration (FDA) a year ago. In parallel, the Company’s third-party manufacturer submitted responses to the deficiencies identified at the manufacturing facility in the Post-Application Action Letter (“PAAL”) issued by the FDA concurrently with the CRL. DefenCath is being developed as a catheter lock solution with an initial indication of use for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with renal failure who are receiving chronic hemodialysis via a central venous catheter. The FDA has 30 days to review the submission for completeness to accept for filing and provide guidance on the review timeline. Dr. Phoebe Mounts, General Counsel and Head of Technical Operations at CorMedix noted “The CorMedix team will continue to work collaboratively with FDA and our contract manufacturer during the review process for the resubmitted NDA and responses to the PAAL. We believe that we and the manufacturer have adequately addressed the concerns the Agency identified in the CRL and PAAL. As CorMedix has previously announced, FDA has stated that satisfactory resolution of the deficiencies may require a preapproval inspection of the manufacturing facility.” Dr. Matt David, CorMedix interim CEO, commented, “We are pleased to have resubmitted the NDA for DefenCath and appreciate the tremendous efforts of the CorMedix team as well as our third-party manufacturer. We intend to provide updates as appropriate during the review process.” About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory diseases. The Company is focused on developing its lead product DefenCath™, a novel, antibacterial and antifungal solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysi...