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FDA accepts new drug application for IV version of Triferic
Rockwell Medical Inc. announced the FDA has recently accepted the company’s new drug application for its IV formulation of Triferic with a Prescription Drug User Fee Act date set for March 28, 2020.
In May 2019, the company launched dialysate Triferic, the first product from its portfolio. Dialysate Triferic is mixed with liquid bicarbonate to deliver iron to patients via the dialysate, while IV Triferic is designed for intravenous administration to patients, according to a company press release. As a result, if approved, IV Triferic would allow dialysis centers to administer Triferic to patients regardless of the mode of bicarbonate delivery being used.
“We are pleased to announce the FDA’s acceptance of our IV Triferic [new drug application] NDA. This announcement follows shortly after the commercial launch of Dialysate Triferic. If approved, the IV formulation would complement Dialysate Triferic and expand the global market potential of our Triferic portfolio,” Stuart Paul, president and CEO of Rockwell Medical, said.
IV Triferic for adult patients on hemodialysis was developed pursuant to a special protocol assessment, through which the FDA agreed that an equivalence approach to Triferic delivered via dialysate (Dialysate Triferic) would be acceptable for review. The NDA is supported by data from the company’s equivalence study, which demonstrated that IV Triferic delivers the same quantity of iron to patients as the company’s FDA-approved Dialysate Triferic formulation, the company said. An open-label, randomized, multiple-period single-dose study was conducted to establish the equivalence of doses between dialysate and IV administration.
Reference:
http://ir.rockwellmed.com/news-releases/news-release-details/rockwell-medical-inc-announces-acceptance-fda-new-drug