DRs Approved (New Drug Application) or Licensed (Biologic License Application) by FDA Since Publication of Medical Imaging Guidance Documents
| Year(s) of approval or licensure | Product | Indication and key portions of text excerpted from prescribing information |
| 2004 | Kit for the Preparation of Technetium (99m Tc) Fanolesomab | Scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis |
| 2004 and 2005* | Fludeoxyglucose F 18 Injection | Assessment of abnormal glucose metabolism to assist in evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities or in patients with existing diagnosis of cancer |
| Identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging | ||
| Identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures | ||
| 2007 | Ammonia N 13 Injection | Diagnostic PET imaging of myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease |
| 2008 | Iobenguane I 123 Injection | Detection of primary or metastatic pheochromocytoma or neuroblastoma as adjunct to other diagnostic tests |
| 2011 | Ioflupane I 123 Injection | Striatal DAT visualization with SPECT brain imaging to assist in evaluation of adult patients with suspected PS; in these patients, DaTscan may be used to help differentiate essential tremors from tremors attributable to PS |
| 2011 | Sodium Fluoride F 18 Injection | PET imaging of bone to define areas of altered osteogenic activity |
| 2012 | Choline C 11 Injection | PET imaging of patients with suspected prostate cancer recurrence and noninformative bone scintigraphy, CT, or MR imaging findings; in these patients, 11C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation; suspected prostate cancer recurrence is based on elevated blood prostate-specific antigen levels after initial therapy |
| Limitations of use: 11C-choline PET imaging does not replace histologic verification of recurrent prostate cancer | ||
| 2012 | Florbetapir F 18 Injection | PET imaging of brain to estimate β-amyloid neuritic plaque density in adult patients who have cognitive impairment and are being evaluated for AD and other causes of cognitive decline; negative Amyvid scan findings indicate sparse to no neuritic plaques and are inconsistent with neuropathologic diagnosis of AD at time of image acquisition; negative scan findings reduce likelihood that patient’s cognitive impairment is attributable to AD; positive Amyvid scan findings indicate moderate to frequent amyloid neuritic plaques; neuropathologic examination has shown that such quantities of amyloid neuritic plaques are present in patients with AD but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition |
| Limitations of use: positive Amyvid scan findings do not establish diagnosis of AD or other cognitive disorder; safety and effectiveness of Amyvid for predicting development of dementia or other neurologic conditions or for monitoring responses to therapies have not been established |
↵* One new drug application was approved in 2004, and another was approved in 2005; excerpt is from updated labeling for drug approved in 2005. Not included are drugs approved under abbreviated new drug applications (i.e., “generic” drugs). Reference 14 provides full prescribing information for each drug.