Fresenius Kabi Canada has launched Iodixanol Injection 270 and 320, becoming the first company to bring a generic version of injectable iodinated contrast media to the Canadian market. The launch addresses critical supply shortages that have significantly impacted diagnostic imaging procedures across the country.
Health Canada granted Notice of Compliance (NOC) approval for Iodixanol injection on December 17, 2024, for both intravenous and intra-arterial administration. The approval was based on a comprehensive data package demonstrating pharmaceutical equivalence to the reference drug Visipaque®.
Addressing Critical Supply Shortages
The launch comes at a crucial time for Canadian healthcare. In recent years, global shortages of iodinated contrast media have forced Canadian healthcare agencies to adopt rationing strategies, including selecting which patients would receive contrast and reducing dosages where possible. Iodixanol injection was added to Health Canada's tier 3 drug shortage list in June 2022, a classification reserved for shortages likely to have the greatest potential impact on the healthcare system.
"Fresenius Kabi's Iodixanol Injection will be the first generic for injectable iodinated contrast media on the market in Canada," said Lee Fulford, Sr. Marketing Manager, Specialty Pharma at Fresenius Kabi Canada. "With this launch we are committed to bringing value to Canadians, by lowering the cost as well as adding supply stability to a market that has had devastating shortages historically."
Clinical Applications and Product Features
Iodixanol injection is a non-ionic radiographic contrast medium approved for all indications of the reference product Visipaque®. The contrast agent has multiple clinical applications including angiocardiography, arteriography, CT scanning of head and body, excretory urography and venography.
The lower osmolality of Iodixanol Injection, which is isotonic with blood, compared with conventional contrast media of similar iodine concentration can be expected to cause fewer and less severe osmolality-related disturbances, specifically less pain, heat and burning sensation upon injection.
Fresenius Kabi's Iodixanol Injection is preservative-free and comes in polymer bottles with container closures not made with natural rubber latex. The product is available in six presentations for intra-arterial and intravenous procedures, with 270 mg Iodine per mL available in 100 mL and 150 mL polymer bottles, and 320 mg Iodine per mL available in 50 mL, 100 mL, 150 mL, and 200 mL polymer bottles.
Strategic Market Expansion
The launch represents a significant expansion for Fresenius Kabi into the contrast media space in Canada, following recent successful launches of contrast media products in the United States. This expansion into the imaging agent space is identified as a substantial cornerstone of Fresenius Kabi's Vision 2026 and the #FutureFresenius strategy.
"We are proud to be introducing an affordable alternative Iodixanol diagnostic option which will strengthen Canada's supply for this critical agent," said Martin Willner, General Manager, Fresenius Kabi Canada. "This launch underscores our commitment to enhancing patient care through accessible therapies."
