CHALFONT ST GILES, UK--(BUSINESS WIRE)--(BUSINESS WIRE)--The U.S. Food and Drug Administration (FDA) has approved Clariscan™, a macrocyclic, ion, gadolinium-based MRI contrast agent that expands GE Healthcare's product portfolio for American patients and radiologists. Clariscan is a gadolinium-based contrast agent for intravenous use in magnetic resonance imaging (MRI) of the brain (intracranial), spine and related tissues of adult and pediatric patients , To detect and visualize the damaged area of the blood-brain barrier (BBB) and/or abnormal blood vessels.
Clariscan has been approved in more than 55 countries around the world and has shipped more than 4 million patient doses in these countries. It is the latest product in a growing number of imaging agents provided by GE Healthcare in the United States. For more than 40 years, GE reagents have been routinely used in MRI, X-ray/CT, and ultrasound to enhance images and support diagnosis.
"In the past decade, the demand for contrast agents has increased significantly. The launch of Clariscan has increased the clinical services we provide to radiologists in the United States and enhanced visualization to provide better patient care. Our customers rely on our high Quality products, first-class supply network and peripheral services support their daily work," explained Kevin O'Neill, President and CEO of GE Healthcare's Drug Diagnostics Division.
"The FDA's approval of this macrocyclic MR agent increases the choice of contrast agents available in the United States, and as radiologists, we welcome this wider choice," said FACR MD Lawrence N Tanenbaum.
GE Healthcare provides diagnostic imaging agents used in approximately 90 million operations worldwide each year, equivalent to three patients per second. In the United States, GE Healthcare has a good record of innovation in new contrast media products and indications. Recently the FDA approved Omnipaque™ (iohexol) for abdominal CT and Visipaque™ (iodine) for coronary CT angiography. Dexanol). In the past five years, GE Healthcare has invested US$240 million in its global manufacturing and supply network to provide imaging agents to hospitals and pharmacies worldwide.
Clariscan is manufactured in Norway using a proprietary manufacturing process. As with all GE Healthcare contrast media products, all manufacturing stages from the development of the active pharmaceutical ingredient (API) to the finished product are fully managed by GE Healthcare. Clariscan offers single-dose vials of 10, 15 and 20 mL. The packaging on each Clariscan package contains a 2D data matrix (barcode) that conveys key information, including national drug codes, individual batch numbers, and expiration dates. This information can be easily scanned and uploaded to the electronic medical system, which helps reduce the risk of manual data entry errors and helps improve the efficiency of the medical center's workflow.
GE Healthcare is a US$19.8 billion healthcare business under GE (NYSE: GE). As a leading supplier of medical imaging, monitoring, biomanufacturing, and cell and gene therapy technologies, GE Healthcare achieves precise health in diagnosis, treatment and monitoring through smart devices, data analysis, applications and services. The company has more than 100 years of experience in the healthcare industry and more than 50,000 employees worldwide, helping patients, healthcare providers, researchers, and life science companies around the world to improve results more effectively. Follow us on Facebook, LinkedIn, Twitter and The Pulse for the latest news, or visit our website https://corporate.gehealthcare.com/ for more information.
CLARISCANTM (gadolinium meglumine) injection for intravenous use
CLARISCAN™ (gadolinium meglumine) is a gadolinium-based contrast agent for intravenous magnetic resonance imaging (MRI) injections of the brain (intracranial), spine and related tissues in adults and children to detect and visualize blood interruptions Regional brain barrier (BBB) and/or abnormal blood vessels.
Guerbet LLC's Dotarem (gadoterate meglumine injection) received additional pediatric use information. However, due to Guerbet LLC’s marketing exclusivity, the drug was not labeled with the pediatric information.
Important safety information about CLARISCANTM
Warning: Nephrogenic Systemic Fibrosis (NSF) For the complete black box warning, please refer to the complete prescribing information.
Gadolinium contrast agents (GBCA) increase the risk of NSF in patients with impaired drug clearance. Avoid using GBCA in these patients unless diagnostic information is essential and cannot be obtained by non-contrast MRI or other means. NSF can cause fatal or debilitating fibrosis, affecting the skin, muscles, and internal organs.
There is a history of clinically important hypersensitivity to Clariscan.
Guerbet, LLC's Dotarem (gadoterate meglumine injection) received additional pediatric usage information. However, due to Guerbet LLC’s marketing exclusivity, the drug was not labeled with the pediatric information.
Before administering Clariscan, please read the complete prescribing information, including boxed warnings and patient medication guidelines. For more important safety information, please visit:
https://www.gehealthcare.com/-/media/A4F1C1C8F50D489387BF91292DBA5629.pdf
To report a suspicious adverse reaction, please contact GE Healthcare at 800-654-0118, or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional safety information about Omnipaque™, please refer to the full prescribing information on https://www.gehealthcare.com/-/jssmedia/c66966a70fe946afa829483a1d6c848c.pdf?la=en-us
For additional safety information about Visipaque™, please refer to the full prescribing information on https://www.gehealthcare.com/-/jssmedia/1f0478f5573f47538b0e4bdcc619ac3c.pdf?la=en-us
Media Contact: Sophie White Communications +44 78255882977 sophie.white@ge.com
Media Contact: Sophie White Communications +44 78255882977 sophie.white@ge.com