CorMedix Refiles DefenCath US Application For Catheter-Related Bloodstream Infections
CorMedix Inc (NASDAQ: CRMD) has resubmitted the New Drug Application (NDA) for DefenCath to address the Complete Response Letter (CRL) issued by the FDA.
In parallel, the Company's third-party manufacturer submitted responses to the deficiencies identified at the manufacturing facility in the Post-Application Action Letter issued by the FDA concurrently with the CRL.
In March last year, the FDA issued a CRL noting concerns at the third-party manufacturing facility.
DefenCath is being developed as a catheter lock solution with an initial indication of use to reduce catheter-related bloodstream infections in patients with renal failure 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, "as CorMedix has previously announced, FDA has stated that satisfactory resolution of the deficiencies may require a preapproval inspection of the manufacturing facility."
Price Action: CRMD shares are up 20.90% at $4.86 during the market session on the last check Monday.
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