FDAnews Device Daily Bulletin

Eli Lilly has misbranded its radioactive PET drug Amyvid, approved for reviewing displays of brain scans using a black-and-white scale, by featuring a multi-colored brain image on a web page advertisement and other promotional materials for the product, according to an FDA untitled letter. The materials misleadingly suggest that Amyvid (florbetapir F 18 injection) PET images can be displayed, and therefore interpreted, in color for patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. However, this is not the case, according to the letter, recently posted to the agency’s website.
Devices & Diagnostics Letter