Ua hoʻolaha ʻo KYE Pharmaceuticals Inc. i kēia lā ua waiho ʻo ia i kahi New Drug Submission (NDS) i Health Canada no ka loiloi hoʻoponopono a me ka ʻae ʻana o Accrufer® (ferric maltol).
Inā ʻae ʻia, ʻo Accrufer® ka lāʻau lapaʻau mua wale nō i ʻae ʻia e Health Canada a ke manaʻo ʻia nei ka ʻae ʻana o ke kālepa no Accrufer® i ka hapa mua o 2023.
Ua ʻōlelo ʻo Doug Reynolds, Pelekikena o KYE: "Ua hana nui nā hui Shield a me KYE e hōʻuluʻulu i ka NDS Kanada i loko o kekahi mau mahina a hauʻoli nui wau i ka hoʻokō ʻana i kēia milestone."
Ua hoʻohui ʻo José A. Menoyo, MD, Luna Nui o ka Lapaʻau no Shield: "Ua hauʻoli mākou i ka holomua wikiwiki i hana ʻia me KYE mai ke kau inoa ʻana o ka ʻaelike laikini i Ianuali. Ua hōʻike nā hui ʻelua i ka hui like ʻana a ua hoʻoikaika ʻia e hoʻolako iā Accrufer® i nā poʻe maʻi ma Kanada me ka hemahema hao i ka wikiwiki. Ua kūpaʻa ʻo Shield Therapeutics i ka lawe ʻana iā Accrufer®/Feraccru® i nā poʻe maʻi me ka hemahema hao a puni ka honua, a ʻo Kanada kahi mea nui o kēlā misionari.
He aha e lawe ʻia mai kēia ʻatikala:
- “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.
- 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.
- today announced it has submitted a New Drug Submission (NDS) to Health Canada for the regulatory review and approval of Accrufer® (ferric maltol).
