FDA Approves GE Healthcare’s Macrocyclic MRI Contrast Agent

The U.S. Food and Drug Administration (FDA) has approved Clariscan, a macrocyclic, ionic, gadolinium-based, MRI contrast agent, expanding the GE Healthcare portfolio for U.S. patients and radiologists. Clariscan is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
 
Clariscan has been approved in more than 55 countries globally and has had more than four million patient doses shipped in those countries. It is the latest in a growing range of imaging agents available in the U.S. from GE Healthcare. For more than 40 years, GE agents have been routinely used across MRI, X-ray/CT and ultrasound to enhance the image and support diagnosis. 
 
“Demand for contrast media has significantly increased over the past decade. The introduction of Clariscan increases our clinical offering for U.S. radiologists, enhancing visualization to provide better patient care. Our customers rely on our high-quality products, first-rate supply network, and surrounding services to support their day-to-day work,” explained Kevin O’Neill, President & CEO Pharmaceutical Diagnostics at GE Healthcare.
 
“The FDA’s approval of this macrocyclic MR agent adds to the range of contrast media options available here in the U.S. and as radiologists we welcome this broader choice,” said Dr. Lawrence N Tanenbaum, M.D., FACR.
 
GE Healthcare offers diagnostic imaging agents used in approximately 90 million procedures per year globally, equivalent to three patients every second. In the U.S., GE Healthcare has a strong record of innovation in new contrast media products and indications, with recent FDA approvals for Omnipaque™ (iohexol) in CT of the abdomen and for Visipaque™ (iodixanol) in coronary CT angiography. GE Healthcare has invested $240 million in its global manufacturing and supply network over the past five years to deliver imaging agents to hospitals and pharmacies globally.
 
Clariscan is manufactured in Norway using a proprietary manufacturing process. As with all GE Healthcare contrast media products, all stages of manufacturing, from development of the active pharmaceutical ingredient (API) to finished product, are managed entirely by GE Healthcare. Clariscan is available in single dose vials of 10, 15 and 20 mL. The packaging contains a 2D data matrix (barcode) on every Clariscan pack, which conveys key information, including national drug code number, individual lot number, and expiration date. This information can be easily scanned and uploaded onto electronic medical systems, helping to reduce the risk of manual data entry errors and helping workflow efficiencies at medical centers.