FDA CDER assigned for pre-market review of CorMedix's Neutrolin

CorMedix Inc. ("CorMedix") (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of Cardiorenal disease, today announced that on September 15, 2011, the U.S. Food and Drug Administration (the "FDA") advised CorMedix, that the Center for Drug Evaluation and Research ("CDER") has been assigned as the lead agency for the pre-market review of Neutrolin^®.

“We look forward to working with CDER's anti-infective products group at the FDA in the development of Neutrolin”

The Company will request a pre-Investigational New Drug ("pre-IND") meeting with the FDA in preparation of filing an Investigational New Drug ("IND") application. The FDA has 60 days to respond to the pre-IND meeting request. Once the Company submits an IND, the FDA has a statutory 30 days to review the IND submission. Once the FDA accepts the Company's IND, the Company can begin clinical studies.

"We look forward to working with CDER's anti-infective products group at the FDA in the development of Neutrolin," stated, Mark A. Klausner, Chief Medical Officer.