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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 | Fludeoxyglucose F 18 Injection, North Shore LIJ Research, Approval | Fludeoxyglucose F18 Injection, North Shore/LIJ, Manufacturing Change | Fludeoxyglucose F18 Injection, Weill Medical College, Manufacturing Change | Fludeoxyglucose F-18 Injection, Feinstein Institute for Medical Research, Labeling Revision | Fludeoxyglucose [F-18] Injection, The Feinstein Institute for Medical Research, Labeling Revision | Fludeoxyglucose F18 Injection, PETNET Solutions, Inc., Approval
  
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