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CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting For New Drug Application For Defencath Is Not Needed; PDUFA Date Remains February 28, 2021

PDUFA date remains February 28, 2021 Potentially the first antibacterial and antifungal catheter lock solution in the US to prevent catheter related infections in hemodialysis patients BERKELEY HEIGHTS, N.J.,

· 11/18/2020 08:31
  • PDUFA date remains February 28, 2021

  • Potentially the first antibacterial and antifungal catheter lock solution in the US to prevent catheter related infections in hemodialysis patients

BERKELEY HEIGHTS, N.J., Nov. 18, 2020 (GLOBE NEWSWIRE) -- CorMedix Inc. (NYSE: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 decided to cancel the Antimicrobial Drug Advisory Committee meeting tentatively scheduled for January 14, 2021 to discuss the New Drug Application (NDA) for Defencath®. When the FDA accepted for filing the Company’s submitted NDA and granted priority review, it 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 was planning to hold an advisory committee meeting to discuss the application for Defencath to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter related blood stream infections (CRBSI) and that it had not identified any potential review issues at that time. CorMedix has been notified that based on the Agency’s ongoing dialogue with the Company, discussion at an advisory committee is not needed, and it will continue to work on the application with CorMedix during the remainder of the review cycle.

Khoso Baluch, CorMedix CEO commented, “We are very happy with the level of engagement between FDA and the CorMedix team during the NDA review process. We look forward to completion of the review of the NDA and are considering all strategic options to be able to successfully bring Defencath to the U.S. market as soon as possible.”

Phoebe Mounts, CorMedix Executive Vice President and General Counsel, further added, “It is gratifying that the tremendous effort of the CorMedix team has resulted in continuing progress with the FDA in the review of the NDA and that the decision was made that no discussion with an advisory committee is needed. We intend to continue our effort and dialogue with the Agency to ensure that the priority review process can be completed expeditiously to address the unmet medical need of hemodialysis patients for an antimicrobial catheter lock solution to prevent life-threatening CRBSI.”