Posted by Michael Wonder on 21 Jun 2023
CorMedix announces FDA acceptance of resubmission of new drug application for DefenCath
21 June 2023 - CorMedix today announced that the resubmission of the new drug application for DefenCath has been accepted for filing by the US FDA.
The Agency considers the resubmission as a complete, Class 2 response with a six month review, and has assigned a PDUFA target action date of 15 November 2023.
