We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
GLOBETECH PUBLISHING LLC

Download Mobile App




First Macrocyclic and Ionic Gadolinium-Based Contrast Medium Earns US Approval

By MedImaging International staff writers
Posted on 01 Apr 2013
Guerbet (Villepinte, France) reported that the US Food and Drug Administration (FDA) has approved gadoterate meglumine (Dotarem), a gadolinium-based contrast agent (GBCA) designed for intravenous (IV) use with magnetic resonance imaging (MRI) in spine, brain (intracranial), and associated tissues in pediatric and adult patients (two years of age and older) to identify and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Dotarem, which has been commercialized widely worldwide since 1989 and more than 37 million doses administered—is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight (BW). Dotarem injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and prefilled syringes.

MRI has become the cornerstone of CNS imaging since its emergence over 20 years ago. It is estimated that there were more than 10 million contrast-enhanced MRI examinations performed in the United States in 2011, with approximately 60% of these examinations performed to image the CNS.

The Dotarem new drug application (NDA) included two phase III clinical studies. Both phase III studies evaluated the superiority of the enhanced images over the unenhanced images for CNS lesion visualization in all three coprimary endpoints. All defined primary and key secondary efficacy analyses were met and support the efficacy of Dotarem at a standard dose of 0.1 mmol/kg BW. In addition to these two studies, 21 supportive clinical studies evaluated the efficacy and safety of Dotarem-enhanced MRI.

Commercialized widely in over 70 countries in Asia, Africa Europe, Middle East, and South America, more than 37 million doses of Dotarem have been administered. The approved indications for Dotarem may vary between countries. Dotarem is the leading contrast agent in Europe with 47% market share in 2012.

Related Links:
Guerbet


40/80-Slice CT System
uCT 528
X-ray Diagnostic System
FDX Visionary-A
Ultrasound Imaging System
P12 Elite
Medical Radiographic X-Ray Machine
TR30N HF

Channels

Nuclear Medicine

view channel
Image: The diagnostic tool could improve diagnosis and treatment decisions for patients with chronic lung infections (Photo courtesy of SNMMI)

Novel Bacteria-Specific PET Imaging Approach Detects Hard-To-Diagnose Lung Infections

Mycobacteroides abscessus is a rapidly growing mycobacteria that primarily affects immunocompromised patients and those with underlying lung diseases, such as cystic fibrosis or chronic obstructive pulmonary... Read more

Imaging IT

view channel
Image: The new Medical Imaging Suite makes healthcare imaging data more accessible, interoperable and useful (Photo courtesy of Google Cloud)

New Google Cloud Medical Imaging Suite Makes Imaging Healthcare Data More Accessible

Medical imaging is a critical tool used to diagnose patients, and there are billions of medical images scanned globally each year. Imaging data accounts for about 90% of all healthcare data1 and, until... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.