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CorMedix up on FDA acceptance for filing and priority review of Defencath

August 31, 2020

FDA has accepted CorMedix (NYSEMKT:CRMD) +7% filing of new drug application for Defencath its product candidate to be used as a catheter lock solution in hemodialysis 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.

FDA also granted priority review and set a Prescription Drug User Fee Act date of February 28, 2021 for the completion of its review for approval of the NDA.

Source: Press Release

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