Hainan Poly Generic Gadoterate Meglumine Receives Approval in US
LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fresenius Kabi announced today it has launched Gadoterate Meglumine Injection, USP, a bioequivalent and therapeutic equivalent substitute for the contrast agent Dotarem®. This is the second contrast agent introduced by Fresenius Kabi in the United States this year. Fresenius Kabi introduced Iodixanol Injection, USP in July during a nationwide shortage.
Jiangsu Hengrui Medicine`s Generic Gadoterate Meglumine Receives Approval inU.S.
Zydus Pharms' Generic Colestipol Hydrochloride Receives Approval in the U.S.
Health Canada Recalls Dotarem Injection
GE Healthcare`s Generic Gadoterate Meglumine Receives Approval in US
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.
Guerbet LLC takes note of the drug safety communication1 issued on December 19, 2017 by the U.S. Food and Drug Administration (FDA), regarding gadolinium-based contrast agents (GBCAs) and the retention of gadolinium in the body.
Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced today that the US Food and Drug Administration (FDA) has approved Dotarem® (gadoterate meglumine) for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years old, including term neonates, to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).