Fresenius Kabi announced it will introduce a portfolio of generic contrast media agents in the United States, starting immediately with the launch of Iodixanol Injection, USP, a product the U.S. Food and Drug Administration (FDA) lists as being in shortage nationwide. Iodixanol Injection, USP is the first U.S. FDA-approved generic iso-osmolar, dimeric iodinated contrast media agent, which is used during diagnostic x-ray-based imaging such as computed tomography (CT) scans. Iodixanol and other contrast media agents are in shortage across the U.S. due to COVID-19 related supply-chain disruptions.

Fresenius Kabi is committed to preventing and mitigating shortages by working closely with its customers, suppliers, and the FDA, and by making long-term investments that support the supply chain of care in the United States. Contrast media agents are essential to patient diagnosis. An estimated 50 million examinations with contrast agents are performed each year in the United States, and as many as half the nation's hospitals have been affected by this shortage.

Iodixanol Injection, USP is bioequivalent and therapeutically equivalent to Visipaque®, rendering it fully substitutable to the brand, and is the first generic iodinated contrast media agent available exclusively from Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. Fresenius Kabi Iodixanol Injection, USP is an option for hospitals and clinics to use in the diagnosis of certain disorders of the brain, blood vessels, heart, kidneys, and other internal organs.2 It is free of preservatives and comes in a polymer bottle. The container closure is not made with natural rubber latex.

Fresenius Kabi Iodixanol Injection, USP 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 and 320 mg Iodine per mL: 50 mL polymer bottle, 100 mL polymer bottle, 150 mL polymer bottle and 200 mL polymer bottle. Adults and pediatric patients 12 years of age and over, Intra-arterial digital subtraction angiography (270 mg Iodine/mL and 320 mg Iodine/mL). Angiocardiography (left ventriculography and selective coronary arteriography), peripheral arteriography, visceral arteriography, and cerebral arteriography (320 mg Iodine/mL).

Pediatric patients less than 12 years of age - Angiocardiography, cerebral arteriography, and visceral arteriography (320 mg Iodine/mL). Adults and pediatric patients 12 years of age and over, Computed tomography (CT) imaging head and body (270 mg Iodine/mL and 320 mg Iodine/mL). Excretory urography (270 mg Iodine/mL and 320 mg Iodine/mL).

Peripheral venography (270 mg Iodine/mL). Coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of patients with suspected coronary artery disease (320 mg Iodine/mL). Pediatric patients less than 12 years of age, CT imaging of the head and body (270 mg Iodine/mL).

Excretory urography (270 mg Iodine/mL).