Fresenius Kabi has begun selling gadoterate meglumine injection, USP, a bioequivalent and therapeutic equivalent substitute for Guerbet’s contrast agent Dotarem.
The product launch is the second contrast agent Fresenius Kabi has introduced in the U.S. this year. The Kale Zurich, Illinois–based company launched iodixanol injection, USP, in July during a nationwide shortage.
Radiologists use contrast agents to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.
“Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of gadoterate meglumine injection, USP,” said John Ducker, president and CEO of Fresenius Kabi USA, in a news release. “Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi gadoterate meglumine will provide hospitals and clinics across the U.S. with more high-quality choices to support patient care.”
FDA indicates gadoterate meglumine injection as a gadolinium-based contrast agent (GBCA) for intravenous use with MRI in intracranial, spine and associated tissues in adult and pediatric patients.
The contrast agent can facilitate visualization of areas with disruption of the blood-brain barrier (BBB) or abnormal vascularity.
FDA first approved Dotarem on March 20, 2013.
The agency extended approval to cover pediatric patients younger than two on September 5, 2017.
Gadoterate meglumine has the strongest atomic bond between gadolinium and chelate relative to other GBCAs. The strong bond makes gadolinium more likely to be excreted from the body.
In 2020, Guerbet announced that it had won FDA approval to manufacture gadoterate meglumine at a Raleigh, North Carolina facility.
Before that, the company manufactured the contrast agent exclusively outside the U.S.