FDA accepts Triferic for treatment of Iron Deficiency in CKD patients- Rockwell Medical
Rockwell Medical has announced that its New Drug Application (NDA) for Triferic (soluble ferric pyrophosphate citrate) has been accepted for filing by the FDA. Triferic is the Company's iron-replacement drug for treating Iron Deficiency in chronic kidney disease patients receiving hemodialysis. The acceptance of the NDA indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of January 24, 2015. The PDUFA action date is the goal date for the FDA to complete its review of the NDA.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
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