Rockwell Medical (RMTI) Submits New Drug Application For Triferic™ For The Treatment Of Iron Replacement In Chronic Kidney Disease Patients On Hemodialysis
3/24/2014 8:55:12 AM
WIXOM, Mich., March 24, 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 the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Triferic (soluble ferric pyrophosphate citrate), the Company's late-stage investigational iron-replacement drug for treating iron deficiency in chronic kidney disease patients receiving hemodialysis. The NDA submission is based primarily on the datasets derived from the Triferic Phase 3 registration study program, and includes efficacy and safety data from additional studies.
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