CorMedix Inc. announced that the resubmission of the New Drug Application (NDA) for DefenCath has been accepted for filing by the U.S. Food and Drug Administration (FDA). The Agency considers the resubmission as a complete, Class 2 response with a six-month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 15, 2023. DefenCath is being developed as a catheter lock solution with an initial indication of use for the reduction of catheter-related bloodstream infections (CRBSIs) in patients with kidney failure who are receiving chronic hemodialysis via a central venous catheter.
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05-28 | CorMedix Shares Rise on Multiyear DefenCath Supply Deal | MT |
05-28 | CorMedix Inc. Announces Commercial Agreement with Top Tier Dialysis Provider | CI |
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- CorMedix Inc. Announces FDA Acceptance of Resubmission of New Drug Application for DefenCath