Triferic filed at FDA for treatment of Iron Deficiency in CKD
Rockwell Medical, Inc. a fully-integrated biopharmaceutical company targeting End-Stage Renal Disease and Chronic Kidney Disease with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced the submission of a New Drug Application (NDA) to the 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 III registration study program, and includes efficacy and safety data from additional studies.
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