Fresenius Kabi announced the launch of Iodixanol Injection, a generic equivalent to Visipaque®.

Due to COVID-19 related supply-chain disruptions, Iodixanol and other contrast media agents have been in shortage nationwide. Iodixanol Injection is bioequivalent and therapeutically equivalent to Visipaque and is fully substitutable for the brand.

Iodixanol Injection is a radiographic contrast agent indicated for:

  • Intra-arterial procedures
    • Adults and pediatric patients 12 years of age and older: intra-arterial digital subtraction angiography, angiocardiography, peripheral arteriography, visceral arteriography, and cerebral arteriography.
    • Pediatric patients less than 12 years of age: angiocardiography, cerebral arteriography, and visceral arteriography.
  • Intravenous procedures
    • Adults and pediatric patients 12 years of age and older: computed tomography (CT) imaging of the head and body, excretory urography, peripheral venography, and coronary computed tomography angiography (CCTA) to assist diagnostic evaluation of patients with suspected coronary artery disease.
    • Pediatric patients less than 12 years of age: CT imaging of the head and body and excretory urography.

Fresenius Kabi’s Iodixanol Injection is a preservative free solution available as 270mg iodine per mL in 100mL and 150mL single-dose polymer bottles. It is also available as 320mg of iodine per mL in 50mL, 100mL, 150mL, and 200mL single-dose polymer bottles.

“Fresenius Kabi is pleased to help expand access to affordable, high-quality contrast media agents for the radiology community,” said John Ducker, president and CEO of Fresenius Kabi USA. “The approval and US availability of Fresenius Kabi Iodixanol Injection, USP is expected to provide immediate relief to the current shortage.”

According to the Company, nearly a billion dollars has been invested in US manufacturing and distribution to strengthen the supply chain of essential medicines.

Reference

Fresenius Kabi introduces generic Iodixanol contrast media agent. News release. Fresenius Kabi. Accessed July 18, 2022. https://www.businesswire.com/news/home/20220718005543/en/Fresenius-Kabi-Introduces-Generic-Iodixanol-Contrast-Media-Agent