Drug Resistance
FDA Grants Ceragenix's Request for Designation
Published in Medical Letter on the CDC and FDA, July 1st, 2007
Ceragenix Pharmaceuticals, Inc. (OTCBB:CGXP), a biopharmaceutical company focused on infectious disease and dermatology, 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.
The antimicrobial wound dressing is a combination product that combines EpiCeram(R)...
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