PET Fludeoxyglucose F18 Injection Gains FDA Clearance
March 10, 2011 – The U.S. Food and Drug Administration (FDA) has granted an abbreviated new drug application (ANDA) for a fludeoxyglucose (FDG) F18 injection. Siemens PETNet Solutions is the first commercial manufacturer and distributor to achieve approval of an ANDA for F18 FDG.
F18 is used in oncology for the assessment of abnormal glucose metabolism to assist in the evaluation of known or suspected abnormalities. In cardiology, it is used together with myocardial perfusion imaging to assist in identifying left ventricular myocardium with residual glucose metabolism. It can also be used to identify reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction. In neurology, F18 is used for the identification of regions of abnormal glucose metabolism associated with epileptic seizure foci.
Because radiation-emitting products may increase the risk for cancer, especially in pediatric patients, the smallest dose necessary for imaging should be used. In the oncology and neurology settings, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. Medical therapy and lab testing may be used to assure at least two days of normal levels prior to FDG administration. Hypersensitivity reactions with itching, edema and rash have been reported, therefore emergency resuscitation equipment and personnel should be available.
For more information: www.siemens.com/healthcare
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