CRMD - CorMedix meets FDA to resolve issues in CRL for DefenCath

CorMedix (CRMD) has met with the FDA to discuss solutions to the deficiencies identified in the Complete Response Letter (“CRL”) to its marketing application for DefenCath™ (taurolidine/heparin catheter lock solution).The discussions have also involved the third-party manufacturer (“CMO”) who was cited by the FDA in the CRL after a review of the records.As required by the FDA in the CRL, the company has agreed to a protocol for the manual extraction study for confirmation of in-process controls.The study is expected to indicate that the labeled volume can be consistently withdrawn from the vials. The company anticipates fulfilling the requirement within several weeks.In early March, CorMedix dropped sharply after announcing that the FDA has declined to approve its marketing application for DefenCath™ (taurolidine/heparin catheter lock solution).

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CorMedix meets FDA to resolve issues in CRL for DefenCath