Item 8.01 Other Events
On August 8, 2022, CorMedix Inc. (the "Company") issued a press release
announcing that a second Complete Response Letter was received from the U.S.
Food and Drug Administration ("FDA"), stating that the New Drug Application
("NDA") for DefenCath cannot be approved until the deficiencies conveyed to the
contract manufacturing organization and the supplier of the active
pharmaceutical ingredient heparin during inspections are resolved to the
satisfaction of FDA.
A copy of the press release is filed as Exhibit 99.1 to this Current Report on
Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. Description
99.1 Press Release dated August 8, 2022
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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