CorMedix hit with second CRL for antifungal treatment, citing manufacturing and API issues
Following a C-suite shuffle, a shuttering of its European operations and a CRL for its treatment to prevent bloodstream infections in patients undergoing chronic hemodialysis, CorMedix is still not impressing the FDA.
The biotech has now been given a second rejection letter, as the NDA surrounding its antifungal solution, DefenCath, cannot be approved until issues surrounding its contract manufacturing organization and the supplier of the API heparin during inspections are resolved, CorMedix said Monday afternoon.
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