CorMedix, Inc., a pharmaceutical company focused on developing and commercializing therapeutic products to prevent and treat cardiorenal disease, today detailed its latest correspondence from the U.S. Food and Drug Administration (FDA) regarding the company’s regulatory submission for Neutrolin®.
Neutrolin is the CorMedix’s candidate for the prevention of catheter-related bloodstream infections. The company recently filed a Request for Designation (RFD), which allows the FDA to determine the product type and assign the product to the appropriate lead center.
In its filing, CorMedix proposed for Neutrolin to be classified as a device and assigned to the Center For Devices and Radiological Health as lead reviewer. The company noted that the RFD filing is the company’s response to communication from the FDA following CorMedix’s Investigational Device Exemption (IDE) amendment submission.
If the FDA hasn’t responded with a designation letter within 60 calendar days of the filing of the RFD, CorMedix’s recommendation will stand as the designated classification and assignment.
CorMedix expects to launch its clinical study of Neutrolin in the second half of 2011, contingent on the pending device designation and IDE approval.
CorMedix also said it expects to complete the initial submission of the Neutrolin Design Dossier to the European notified body by the end of the second quarter 2011.
For more information visit www.cormedix.com