CorMedix announced the US Food and Drug Administration (FDA) has granted the request for a rolling review of the New Drug Application (NDA) for Neutrolin® for the prevention of catheter-related blood stream infections (CRBSIs) in hemodialysis patients. Neutrolin has received Fast Track Designation from FDA and the Company confirmed with FDA in a pre-NDA meeting that it was eligible to request a rolling review. A rolling submission of the NDA is designed to expedite the review process for products being developed to address an unmet medical need. CorMedix remains on schedule for a potential NDA approval during the second half of 2020.
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“We are very proud of the achievement by the CorMedix Team of reaching this significant milestone for Neutrolin,” Khoso Baluch, CorMedix Chief Executive Officer, said. “We are also grateful to FDA for its continuing cooperation, as we work diligently to secure regulatory approval of Neutrolin in the US to prevent life-threatening CRBSIs in hemodialysis patients.”