KYE Pharmaceuticals Inc. today announced it has submitted a New Drug Submission (NDS) to Health Canada for the regulatory review and approval of Accrufer® (ferric maltol).
If approved, Accrufer® would be the first prescription only oral iron therapy approved by Health Canada and marketing approval for Accrufer® is expected to be during the first half of 2023.
Doug Reynolds, President of KYE, said: “The Shield and KYE teams worked tremendously hard to compile the Canadian NDS in a matter of months and I am extremely pleased to have achieved this milestone.”
José A. Menoyo, MD, Chief Medical Officer for Shield, added: “We are delighted with the rapid progress made in partnership with KYE since the signing of the license agreement in January. Both organizations have demonstrated excellent collaboration and are driven to make Accrufer® available to patients in Canada with iron deficiency as quickly as possible. Shield Therapeutics is committed in bringing Accrufer®/Feraccru® to patients with iron deficiency around the world, and Canada is an important element of that mission.”
