KYE Pharmaceuticals Inc. leo imetangaza kuwa imewasilisha Uwasilishaji Mpya wa Dawa (NDS) kwa Afya Kanada kwa ukaguzi wa udhibiti na uidhinishaji wa Accrufer® (ferric maltol).
Ikiidhinishwa, Accrufer® itakuwa dawa ya kwanza pekee ya matibabu ya kumeza ya chuma iliyoidhinishwa na Health Canada na idhini ya uuzaji kwa Accrufer® inatarajiwa kuwa katika nusu ya kwanza ya 2023.
Doug Reynolds, Rais wa KYE, alisema: "Timu za Shield na KYE zilifanya kazi kwa bidii sana kuunda NDS ya Kanada katika muda wa miezi kadhaa na nimefurahiya sana kufikia hatua hii muhimu."
José A. Menoyo, MD, Afisa Mkuu wa Matibabu wa Shield, aliongeza: “Tunafurahishwa na maendeleo ya haraka yaliyopatikana kwa ushirikiano na KYE tangu kusainiwa kwa mkataba wa leseni mwezi Januari. Mashirika yote mawili yameonyesha ushirikiano bora na yanasukumwa kufanya Accrufer® ipatikane kwa wagonjwa nchini Kanada walio na upungufu wa madini ya chuma haraka iwezekanavyo. Shield Therapeutics imejitolea kuleta Accrufer®/Feraccru® kwa wagonjwa walio na upungufu wa madini ya chuma kote ulimwenguni, na Kanada ni sehemu muhimu ya dhamira hiyo.
NINI CHA KUONDOA KATIKA MAKALA HII:
- “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).
