Web Page for Imaging Agent Amyvid Misleading, FDA Says in ‘Untitled’ Letter

The Food and Drug Administration told Eli Lilly and Co. that a web page for Amyvid (florbetapir F 18 injection) is misleading, according to an “untitled” letter posted Sept. 7 on FDA’s website.

Amyvid is indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer’s, and is detected using positron emission tomography (PET) scan images of the brain. FDA approved Amyvid in April (10 PLIR 500, 4/13/12).

FDA said the page features a ...