CorMedix's DefenCath NDA Re-submission Accepted By FDA, Sets Target Action Date

(RTTNews) - CorMedix Inc. (CRMD), a biopharmaceutical company specializing in therapeutic products for critical diseases, on Wednesday, announced that the U.S. Food and Drug Administration or FDA has accepted the re-submission of the New Drug Application for DefenCath.

The FDA has classified the resubmission as a complete, Class 2 response and has assigned a Prescription Drug User Fee Act target action date of November 15.

DefenCath is being developed as a catheter lock solution primarily aimed at reducing catheter-related bloodstream infections in patients with kidney failure who receive chronic hemodialysis via a central venous catheter.