Posted by Michael Wonder on 31 Aug 2020
CorMedix announces FDA acceptance for filing and priority review of new drug application for Defencath
31 August 2020 - FDA sets PDUFA goal date of 28 February 2021.
CorMedix today announced that the U.S. FDA has accepted for filing the Company’s submitted new drug application for Defencath, its product candidate to be used as a catheter lock solution in haemodialysis patients for the prevention of catheter related blood stream infections.
The FDA had previously granted a rolling submission and review, which the Company completed at the end of June.
The Agency noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at this time.
