FDA approves Guerbet's contrast agent Dotarem

France-based Guerbet (GBT: FP) says that the US Food and Drug Administration has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (two years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

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

"This approval is a major milestone for Guerbet, which has a proud history of providing safe and effective contrast agents to patients worldwide," said Yves L'Epine, chief executive of Guerbet, adding: "Dotarem - already a leader in Europe – is a compelling new CNS imaging option for US healthcare providers and enriches our portfolio for improved patient management with diagnostic imaging in the USA."