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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