There has been an interruption in the supply of AquADEKs Chewable Tablets. This medication has been available through Health Canada’s Special Access Program. Due to the recommended dose of Vitamin K limited to 120 μg/day in Canada, there have been supply issues with AquADEKs (which provides 700 μg/day). Health Canada requested that Yasoo, the manufacturer, apply for a Drug Identification Number for AquADEKs products. AquADEKs Chewable received a negative regulatory decision, consequently Health Canada have placed a hold on interim requests received.
Production to satisfy the back order will be dispatched to patients once it is received at the end of September. Health Canada will relieve this hold once Yasoo and their distributor Aptalis, submit their next steps with respect to addressing and disclosing the issues of the Notice of Deficiency and plans for market approval in Canada for AquADEKs. Both Yasoo and Aptalis are engaged in talks to resolve this hold. Cystic Fibrosis Canada, working with the Policy Advisory Panel on Access to Medicines, will monitor progress closely and keep you informed.
Cystic Fibrosis Canada continues to actively advocate for equitable access to CF therapeutic products.