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Eli Lilly PET Drug Misbranded by Misleading Imagery, FDA Says
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 webpage 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.
Washington Drug Letter |
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