What is the generic name?

FLORBETABEN F 18

What is the Trade Name for FLORBETABEN F 18?

Neuraceq

What are the Indications for FLORBETABEN F 18?

• 1 INDICATIONS AND USAGE Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate Œ≤-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer‚Äôs Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no amyloid neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient‚Äôs cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is 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. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use ‚Ä¢ A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. ‚Ä¢ Safety and effectiveness of Neuraceq have not been established for: ‚Ä¢ Predicting development of dementia or other neurologic conditions; ‚Ä¢ Monitoring responses to therapies. Neuraceq ¬Æ is a radioactive diagnostic agent indicated for Positron Emission Tomography (PET) imaging of the brain to estimate Œ≤-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer‚Äôs Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient‚Äôs cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is 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. Neuraceq is an adjunct to other diagnostic evaluations. Limitations of Use ‚Ä¢ A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. ‚Ä¢ Safety and effectiveness of Neuraceq have not been established for: ‚Ä¢ Predicting development of dementia or other neurologic conditions ‚Ä¢ Monitoring responses to therapies

References: https://open.fda.gov/