GE Healthcare ($GE) has gotten FDA approval for its plant in Oslo, Norway, to make a heart imaging agent. The company said that with approval, it will be the only contrast media manufacturer to supply its own stock to the U.S.
The product is Optison (perflutren protein-Type A microspheres injectable suspension, USP). It is a contrast agent that can be used in diagnosing some heart diseases by improving the visualization of the left ventricular border, the company said.
GE spokesman Scott Lerman said in an email that the Oslo plant has been around for about 10 years and is where GE manufactures a number of its core imaging products, including Omnipaque, Visipaque, DaTscan, Myoview and CereTec. He said the company recently invested "several million dollars to upgrade the Oslo facility" so it could manufacture Optison there, a move that increases capacity for the product. About 350 people work at the faciilty.
GE is a specialist in the field. The FDA last month approved its imaging agent Vizamyl (flutemetamol F18 injection) to detect a toxic protein found clustered in the fogged brains of Alzheimer's patients. The agent, however, can only be used to rule out Alzheimer's if the telltale clusters of beta amyloid are absent. The FDA said it could not be used alone to diagnose the disease--at least until more is known about the role that amyloid plays. Nor does it replace any of the current diagnostic tools now in place.
- here's GE's announcement