Fresenius Kabi Canada launches Iodixanol Injection 270 & 320 - the first and only generic to Visipaque® in Canada

• Fresenius Kabi received Health Canada's Notice of Compliance (NOC) approval for Iodixanol injection on December 17 for both intravenous and intra-arterial administration
• With the launch of Iodixanol injection, Fresenius Kabi Canada is looking to expand into the contrast media space, with a commitment to bring more treatment options for patients requiring diagnostic imaging
• Iodixanol injection is approved for all indications of the reference product Visipaque^® and available immediately

TORONTO, June 4, 2025 /CNW/ - Fresenius Kabi Canada, part of Fresenius group, announced the recent launch of Iodixanol Injection 270 and 320 for both the intravenous and intra-arterial administrations. Iodixanol Injection is a contrast agent with uses in angiocardiography, arteriography, CT scanning of head and body, excretory urography and venography. Health Canada's NOC approval of Iodixanol Injection 270 & 320 was granted on December 17, 2024, and is based on a thorough evaluation of a comprehensive data package demonstrating pharmaceutical equivalence to the reference drug Visipaque^®.

With this approval, Fresenius Kabi is building its footprint in the contrast media space in Canada, following recent successful launches of contrast media products in the United States. Expanding a strong presence into the imaging agent space is a substantial cornerstone of Fresenius Kabi's Vision 2026 and the #FutureFresenius strategy.

"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."  

In recent years global shortages of iodinated contrast media have led to Canadian healthcare agencies having to adopt strategies to mitigate shortages including selecting which patients would get contrast and reducing dosages where possible¹. Iodixanol injection was added in June 2022 to Health Canada's tier 3 drug shortage list. Tier 3 drug shortages are those likely to have the greatest potential impact to the Health Care system².  

"We are proud to be introducing an affordable alternative Iodixanol diagnostic option which will strengthen Canada's supply for this critical agent. This launch underscores our commitment to enhancing patient care through accessible therapies," said Martin Willner, General Manager, Fresenius Kabi Canada.

About Fresenius Kabi:

Fresenius Kabi, an operating company of Fresenius, specializes in clinical nutrition, medical technologies, and I.V. generics and fluids for the therapy and care of critically and chronically ill patients. With more than 41,000 employees and present in over 100 countries, Fresenius Kabi's expansive product portfolio focuses on providing access to high-quality and lifesaving medicines and technologies.

About Iodixanol Injection

Iodixanol injection is a non-ionic radiographic contrast medium with uses in 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 injection³.

Fresenius Kabi's Iodixanol Injection is free of preservatives and comes in a polymer bottle. The container closure is not made with natural rubber latex. Fresenius Kabi Iodixanol Injection is currently available in six presentations for intra-arterial and intravenous procedures:

270 mg Iodine per mL:

• 100 mL polymer bottle
• 150 mL polymer bottle

320 mg Iodine per mL:

• 50 mL polymer bottle
• 100 mL polymer bottle
• 150 mL polymer bottle
• 200 mL polymer bottle

For more information, please visit http://www.fresenius-kabi.com/en-ca

References: 

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius Kabi does not undertake any responsibility to update the forward-looking statements in this release.

Management Board: Pierluigi Antonelli (Chairman), Marc Crouton, Andreas Duenkel, Dr. Christian Hauer,
Dr. Marc-Alexander Mahl, Dr. Sang-Jin Pak
Chairman of the Supervisory Board: Wolfgang Kirsch
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg - HRB 11654

SOURCE Fresenius Kabi Canada Inc.