EU suspends marketing authorization for GE Optison

GE hits marketing wall in Europe for heart contrast agent. Source: Schmidt & Clark

The European Medicines Agency (EMEA) reported last week that the European Commission has suspended the marketing authorization of GE Healthcare's Optison, a diagnostic contrast agent used in echocardiograms.

The EMEA's committee for medicinal products said marketing authorization holder, GE Healthcare, was unable to provide an authorized importer for Optison to ensure the supply of the medicinal product in the European market and prove good manufacturing practice compliance at the manufacturing site in the United States.

The regulators recommended that the marketing authorization for Optison be suspended.

The EMEA noted that Optison currently is not marketed in the European Union.