The company targets end-stage renal disease (ESRD) and chronic kidney disease (CKD) with new products and services to treat iron replacement, secondary hyperparathyroidism and hemodialysis.
Triferic is indicated for treating iron deficiency in chronic kidney disease patients receiving hemodialysis.
The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of 24 January 2015, which is the goal date for the FDA to complete its review of the NDA.
Rockwell founder, chairman and chief executive officer Robert Chioini said the acceptance of this NDA is another significant step in the company’s plan to bring Triferic to market and to offer patients with chronic kidney disease on dialysis a substantially better treatment option for addressing their iron deficiency.
"We look forward to continuing to work closely with the FDA during its review process of Triferic," Chioini said.
The company’s NDA seeks approval for the marketing and sale of the drug 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).
The NDA is based on the safety and efficacy data sets derived from the company’s Phase III registration program, as well as safety and efficacy data from several additional studies including the entire clinical program.