CRMD - CorMedix resubmits marketing application for lead candidate DefenCath

2023-05-16 10:13:55 ET

• CorMedix Inc. ( NASDAQ: CRMD ) announced Tuesday that the company resubmitted its marketing application for lead product candidate DefenCath targeted at reducing the risk of catheter-related infection in kidney disease patients on hemodialysis.
• The Berkeley Heights, New Jersey-based pharma has faced several setbacks in its efforts to launch DefenCath, with the FDA rejecting the antimicrobial agent twice in 2021 and 2022, citing production- related issues, among others.
• The latest New Drug Application submitted to the FDA on Monday is aimed at receiving a potential approval in 2023, Chief Executive of CorMedix ( CRMD ), Joe Todisco, remarked, adding that “the resubmission reflects the hard work of the CorMedix regulatory and technical teams and our strategic partners.”

• We “aim to deliver on our commitment to reducing the risk of infections in patients receiving hemodialysis via central venous catheters, Todisco added.

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