29 May 2019 - I.V. Triferic was developed through Special Protocol Assessment with FDA based on equivalence approach to Dialysate Triferic.

Rockwell Medical today announced that it has completed the submission of its new drug application to the U.S. FDA for the Intravenous (I.V.) formulation of Triferic.

I.V. Triferic for adult haemodialysis patients was developed pursuant to a Special Protocol Assessment (SPA), through which the FDA agreed that an equivalence approach to Triferic delivered via haemodialysate (Dialysate Triferic) would be acceptable for review. The NDA is supported by data from the Company’s equivalence study, which demonstrated that I.V. Triferic delivers the same quantity of iron to patients as the Company’s FDA-approved Dialysate Triferic formulation. An open-label, randomised, multiple-period single dose study was conducted to establish the equivalence of doses between dialysate and I.V. administration.

Read Rockwell Medical press release