GE Healthcare announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison 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. Upon approval, GE Healthcare will provide supply of Optison to the U.S. market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the United States.
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