CorMedix to Resubmit NDA for DefenCath in May
Provided by
Dow Jones
By Chris Wack
CorMedix Inc. said Wednesday that, following its Type A meeting with the U.S. Food and Drug Administration, it intends to resubmit its New Drug Application for DefenCath by the middle of May.
The biopharmaceutical company said that, at the Type A meeting, the FDA informed it that it is in receipt of the close-out report for inspectional observations received from its existing contract manufacturing organization, and NDA resubmission can be done at the company's discretion.
The FDA may conduct a pre-approval inspection at the facility as part of the NDA review process.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
April 26, 2023 09:05 ET (13:05 GMT)
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