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Rockwell Medical Inc announces FDA acceptance for filing of Triferic(TM) new drug application

Wednesday, 28 May 2014 08:03am EDT 

Rockwell Medical Inc:Says its New Drug Application (NDA) for Triferic((tm))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.Says acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review.NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of Jan. 24, 2015.PDUFA action date is the goal date for the FDA to complete its review of the NDA.NDA seeks approval for the marketing and sale of Triferic as an iron replacement therapy for the treatment of iron loss or iron deficiency to maintain hemoglobin in adult patients with hemodialysis-dependent stage 5 chronic kidney disease (CKD 5HD).Included in the NDA filing are safety and efficacy data sets derived from the company's phase 3 registration program, as well as safety and efficacy data from several additional studies comprising the entire clinical program.Results from the clinical trials have shown Triferic to be an effective and highly-differentiated iron delivery therapy with a safety profile similar to placebo. 

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