FDA Grants Ceragenix Pharmaceuticals, Inc.'s Request for Designation

Published: Jun 12, 2007

DENVER--(BUSINESS WIRE)--Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP), a biopharmaceutical company focused on infectious disease and dermatology, today announced that the FDA’s Office of Combination Products, in response to a formal request, has determined that the primary mode of action for an antimicrobial wound dressing that is currently being developed by the Company is that of a device and it has been assigned to the FDA’s Center for Devices and Radiologic Health (CDRH) for lead review. The device will be reviewed through the pre-market approval process to confirm reasonable assurance of safety and effectiveness.

Back to news