News | News By Subject | News by Disease News By Date | Search News
Get Our FREE
Industry eNewsletter
email:    
   

FDA Slams Eli Lilly and Company (LLY) Over Amyvid Site


9/7/2012 6:48:20 AM

Earlier this year, the FDA approved an imaging agent from Eli Lilly for detecting beta-amyloid plaques in patients with cognitive impairment and who are being evaluated for Alzheimer’s disease. Known as Amyvid, this is the first diagnostic agent approved for people who undergo a positron emission tomography, or PET, scan. But the approval was not a slam dunk – the agency initially declined to approve Amyvid over concerns that scans can be accurately read. Now, the FDA has tagged Lilly (LLY) for offering physicians what the agency calls a misleading way to interpret scan results on the Amyvid web site and in recent displays at a medical conference. To wit, Lilly offered a multi-colored image of the brain, when the Amyvid labeling information says PET scans should be displayed and reviewed using a black-and-white scale “with the maximum intensity of the scale set to the maximum intensity of all the brain pixels.”

Read at Pharmalot

comments powered by Disqus
Pharmalot
   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES