FDA Approval Activities for this Drug…

Fludeoxyglucose F-18 Injection, Downstate Clincal PET Center - The Meth. Med. Ctr. of IL. NDA 20-306 6/2/00 6/9/00 6/9/00 6/4/01 Fludeoxyglucose Indications: (a)Assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer. (b) Assessment of patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function. Fludeoxyglucose F 18 Injection, Weill Medical, Approval

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