Rockwell Medical (RMTI) Announces FDA Acceptance For Filing Of Triferic™ New Drug Application
5/28/2014 9:17:00 AM
WIXOM, Mich., May 28, 2014 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, today announced that its New Drug Application (NDA) for Triferic™ has been accepted for filing by the U.S. Food & Drug Administration (FDA). Triferic is the Company's iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of January 24, 2015. The PDUFA action date is the goal date for the FDA to complete its review of the NDA.
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