On August 5, 2004, the Food and Drug Administration (FDA) approved a new drug application (NDA) for Fludeoxyglucose F 18 Injection ([18F]FDG) submitted by Weill Medical College of Cornell University, Citigroup Biomedical Imaging Center. The NDA was approved according to the streamlined procedures outlined in a March 2000 guidance on the approval of positron emission tomography (PET) drugs. The Weill Medical College application was approved in less than 6 months. Although approved applications are not yet required for PET drugs, FDA encourages PET centers to submit applications for approval and is committed to working closely with applicants during the drug approval process.
[18F]FDG is a positron emission tomography (PET) drug used in diagnostic imaging. On March 10, 2000, FDA announced [18F]FDG to be safe and effective for certain indications when produced under conditions specified in approved applications (see Federal Register, Vol. 65, No. 48, 12999-13010). In accordance with the Food and Drug Administration Modernization Act of 1997, FDA developed a draft guidance for industry entitled PET Drug Applications – Content and Format for NDA’s and ANDA’s (Positron Emission Tomography (PET). This guidance outlines a simplified process that PET producers can use to demonstrate that their drug meets quality standards. Weill Medical College of Cornell University, Citigroup Biomedical Imaging Center in New York City submitted the NDA in response to the FDA announcements.
[18F]FDG is indicated in positron emission tomography (PET) imaging for (1) 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; (2) 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; and (3) patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.