Wednesday, June 03, 2020 5:43:09 PM
CORMEDIX INC. ANNOUNCES FDA GRANT OF ROLLING REVIEW OF NEUTROLIN® NEW DRUG APPLICATION
Berkeley Heights, NJ — February 3, 2020 — CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, announced today that the US Food and Drug Administration 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.
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.
http://www.cormedix.com/cormedix-inc-announces-fda-grant-rolling-review-neutrolin-new-drug-application/
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