CorMedix Inc
(Get Free Alerts for 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."
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