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news.GE Healthcare has filed a supplemental new drug application (sNDA) for self manufacturing of Optison (perflutren protein-type A microspheres injectable suspension, USP).
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If approved, GE will manufacture Optison at its Oslo facility thereby becoming the only contrast media manufacturer to supply its own stock to the US market.
GE Healthcare Medical Diagnostics core imaging general manager Stephen Lightfoot said, "While we cannot predict a timeline for regulatory authority approval, we look forward to servicing the US cardiology community directly in 2013."
Optison is a contrast agent designed to improve the visualization of the left ventricular border and is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders.