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Rockwell submits new drug application for iron replacement drug for dialysis patients

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Rockwell Medical Inc. announced the submission of a New Drug Application to the U.S. Food and Drug Administration 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, Rockwell said in a release.