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FDA Strikes Out CorMedix's DefenCath Application

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The FDA has issued a Complete Response Letter for CorMedix Inc's (NASDAQ: CRMD) marketing application seeking approval for DefenCath (taurolidine/heparin catheter lock solution) for catheter-related bloodstream infections.

  • FDA noted concerns at the third-party manufacturing facility after reviewing records, though the agency did not specify the issues.
  • CorMedix will request a meeting with the FDA, which is estimated to happen by mid-April.
  • The company intends to obtain a plan to resolve the problems when the FDA informs the specific concerns.
  • Additionally, FDA requires a manual extraction study to demonstrate that the labeled volume can be consistently withdrawn from the vials despite an existing in-process control to demonstrate fill volume within specifications.
  • FDA did not request additional clinical data and did not identify any efficacy or safety data deficiencies.
  • The draft labeling discussed with the FDA added that the initial approval would be for the limited population of patients with kidney failure receiving chronic hemodialysis through a central venous catheter.
  • Price Action: CRMD shares trading is halted, to resume at 9 am ET.
 

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Posted-In: bloodstream infectionsBiotech News Health Care Small Cap FDA General

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