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Rockwell Medical Inc submits new drug application for Triferic for the treatment of iron replacement in chronic kidney disease patients on hemodialysis


Monday, 24 Mar 2014 08:02am EDT 

Rockwell Medical Inc:Announces submission of a NDA to the USFDA 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 three registration study program, and includes efficacy and safety data from additional studies. 

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