CorMedix Inc. (NASDAQ: CRMD) has announced that the U.S FDA has accepted its resubmission of DefenCath’s New Drug Application (NDA). The FDA has stated that the resubmission is a finished Class II response.
The company is developing DefenCath to be a catheter lock solution. It is for renal failure patients undergoing chronic hemodialysis through central genius gathered. The treatment is to reduce the incidence of infections related to catheters.
The FDA will review the company’s site
According to CorMedix’s General Counsel, Dr. Phoebe Mounts, the company is excited about the FDA’s acceptance of the resubmission of its NDA. Moreover, the company’s contact manufacturer has told executives that the FDA will inspect the site for review.
Mounts adds that CorMedix and its contact manufacturer have successfully addressed the FDA’s concerns and regulations after denying the first submission of the NDA. Furthermore, the company will cooperate with the agency to ensure that the review goes well.
The CFO and Interim CEO of CorMedix, Matt David, M.D., states that the NDA acceptance is a milestone. He adds that CorMedix is dedicated to developing groundbreaking solutions for renal failure patients receiving hemodialysis through central venous catheters.
Dr. David thanks the teams involved in the process. He believes the company will continue to work together to achieve its goals. The company will also reveal details of its earnings and the review soon.
CorMedix is a company that develops and commercializes therapies for inflammatory and infectious diseases. The development of DefenCath is its lead project. This therapy is an antifungal and antibacterial treatment that prevents infection in renal failure patients undergoing hemodialysis through central genius catheters
DefenCath Received Fast Track Designation.
The FDA gave DefenCath a Fast Track Designation. It has now received an NDA since the agency recognizes that it could be instrumental in an area of unmet need. DefenCath has also received the Qualified Infectious Disease Product Designation.
This designation gives the drug five more years of additional marketing exclusivity. If all goes well, the FDA will add another five years to the NDA. Once the NDA is accepted, the company has stated that it will conduct a clinical trial on children undergoing hemodialysis.