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North Shore-LIJ receives FDA approval for new drug application to manufacture PET scan drug

MANHASSET, NY -- The Institute for Medical Research of the North Shore-Long Island Jewish (LIJ) Health System today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture a drug used for diagnostic imaging with positron emission tomography (PET), a scanning technique that generates internal pictures of the human body at work.

The Institute's cyclotron/radiochemistry facility in Manhasset, NY, is the third institution in the United States approved by the FDA to manufacture Fludeoxyglucose F 18 injection, and the only one approved to make it at the highest strength currently available. It is twice the strength of the second institution's drug, and five times the strength of the first, which is no longer on the market.

Because radiopharmaceuticals like Fludeoxyglucose F 18 decay rapidly, they must be used right away. However, the necessity to produce them in a hospital setting and then use them immediately poses a potential safety issue. If Fludeoxyglucose F 18 is contaminated by microorganisms, other chemicals, byproducts or impurities, it may affect the quality of the PET scan result and also pose a danger to patients. Therefore, manufacturing radiopharmaceuticals in a controlled environment that operates under rigorous quality assurance standards is key to safe production.

"The FDA is in the process of instituting regulatory control over the manufacture of radiopharmaceuticals used in PET scanning such as Fludeoxyglucose F 18 to ensure safety to patients and the use of highly controlled manufacturing practices," said Thomas Chaly, PhD, chief of the Institute's cyclotron/radiochemistry facility and the author of its new drug application to the FDA. Regulation is expected within the next few years, he said. FDA approval to manufacture a radiopharmaceutical depends not only on the success of the actual application but a site visit and inspection by the FDA of the facilities, equipment and proced
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Contact: Christina Verni
cverni@nshs.edu
516-562-1232
North Shore-Long Island Jewish (LIJ) Health System
3-Oct-2005


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