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CorMedix : IND For Neutrolin Submitted To FDA - Quick Facts

CorMedix Inc. (CRMD) said that an Investigational New Drug application or IND for Neutrolin was submitted to the United States Food and Drug Administration or FDA on September 24, 2014.

The IND includes a pivotal Phase 3 protocol for Neutrolin in hemodialysis patients with a central venous catheter. The Phase 3 clinical trial is designed as a multi-center, randomized, controlled study conducted in the U.S. and Europe.

Michael Allon, Professor, Department of Medicine, Division of Nephrology, University of Alabama, Birmingham will be the Study Chair of the Neutrolin Phase 3 program. An IND goes into effect 30 days after FDA receives the IND, unless FDA provides notification that the IND is subject to a clinical hold.

Antony Pfaffle, Chief Scientific Officer at CorMedix said, "The filing of our IND is an important incremental step that we believe will lead to the availability of Neutrolin for patients in the US with central venous catheters. Neutrolin is being developed to help prevent catheter-related infections and thrombosis. The active anti-infective ingredient in Neutrolin is taurolidine, which has efficacy against both common and resistant forms of bacteria and fungi. Use of taurolidine has not been associated with the development of microbial resistance in humans."

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