CorMedix has completed its interaction with the FDA related to the chemistry, manufacturing and controls (CMC) package that will be needed to support Neutrolin’s new drug application (NDA). The FDA was supportive of Neutrolin’s proposed manufacturing program, including the active pharmaceutical ingredients (API), the container closure and testing, and indicated that it will conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing facilities at the time of NDA filing. No further CMC meetings with FDA are planned prior to NDA submission.
A pre-NDA meeting has now been scheduled and CorMedix is looking forward to discussing with the FDA the filing of the NDA for Neutrolin®, including the FDA programs intended to facilitate and expedite review of the application, such as Priority Review designation, rolling submission, and LPAD.
“We are very pleased with FDA’s feedback on the CMC package and with the scheduling of a pre-NDA meeting,” Khoso Baluch, President and CEO of CorMedix said. “We are continuing to move forward with preparations for the filing of the NDA for Neutrolin in accordance with our plans, which are focused on obtaining an approval for Neutrolin in adult hemodialysis. We anticipate that Neutrolin can be approved in the second half of 2020 and we intend to launch Neutrolin commercially in the US promptly after its approval either by ourselves or with a partner.”