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CorMedix Inc. Announces FDA Acceptance for Filing and Priority Review of New Drug Application for Defencath
FDA sets PDUFA goal date of February 28, 2021Potentially the first antibacterial and antifungal catheter lock solution in the US to prevent catheter related
About this update from Cormedix Inc.
[{"type":"text","content":"FDA sets PDUFA goal date of February 28, 2021Potentially the first antibacterial and antifungal catheter lock solution in the US to prevent catheter related infections in hemodialysis patients BERKELEY HEIGHTS, N.J., Aug. 31, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s submitted New Drug Application (NDA) for Defencath™, its product candidate to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI). The FDA had previously granted a rolling submission and review, which the Company completed at the end of June. The FDA also granted priority review and set a Prescription Drug User Fee Act (PDUFA) date of February 28, 2021 for the completion of its review for approval of the NDA. The Agency noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time.\n Khoso Baluch, CorMedix CEO commented, “The NDA acceptance is truly a momentous achievement for CorMedix, the internal and external teams involved with the submission, and most importantly, the hemodialysis patient community. We are proud of our team for exceptional effort to get us to this point and look forward to bringing Defencath to patients to prevent the serious complications and costs associated with CRBSI in this significant patient population.” Phoebe Mounts, CorMedix Executive Vice President and General Counsel, further added, “Having been actively involved with the Defencath program and regulatory journey for the past several years, it is very rewarding to have the FDA’s acceptance of our first NDA as an essential step toward our goal of offering Defencath in the U.S. as the first antimicrobial catheter lock solution for the prevention of life-threatening CRBSI in hemodialysis patients. We are very appreciative that the Agency granted priority review and despite the ongoing pandemic, we look forward to continuing to work together expeditiously to complete the review of the Defencath NDA to address an unmet medical ne...