GE Healthcare Gains FDA Approval For Its Own Manufacturing Of Optison

(RTTNews) - GE Healthcare(GE), Monday said it received approval from the U.S. Food and Drug Administration or FDA, to manufacture Optison, on its own.

Optison, Perflutren Protein-Type A Microspheres Injectable Suspension, USP, is a contrast agent that may improve the visualization of the left ventricular border, an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders.

GE Healthcare will provide a supply of Optison to the US and European markets from its manufacturing facility in Oslo, Norway, becoming the only contrast media manufacturer to supply its own stock to the US, following the FDA approval.