Posted by Michael Wonder on 06 Aug 2019
Rockwell Medical announces acceptance by FDA of new drug application for I.V. Triferic
6 August 2019 - FDA establishes PDUFA date of 28 March 2020 for I.V. Triferic
Rockwell Medical announced today that the U.S. FDA has accepted for filing the Company’s New Drug Application (NDA) for its Intravenous (I.V.) formulation of Triferic with a PDUFA (Prescription Drug User Fee Act) date of March 28, 2020.
In May 2019, the Company launched the first product from its portfolio, Dialysate Triferic. Dialysate Triferic is mixed with liquid bicarbonate to deliver iron to patients via the dialysate, while I.V. Triferic is designed for intravenous administration to patients. As a result, if approved, I.V. Triferic would allow dialysis centers to administer Triferic to patients regardless of the mode of bicarbonate delivery being used.
