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FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer's Disease and Other Causes of Cognitive Decline
Date:4/6/2012

0.6 percent), nausea (0.6 percent), anxiety (0.4 percent), back pain (0.4 percent), increased blood pressure (0.4 percent), claustrophobia (0.4 percent), feeling cold (0.4 percent), insomnia (0.4 percent) and neck pain (0.4 percent).[1]

"Florbetapir gives patients with cognitive decline, their families and the physicians who treat them, more information about the amyloid plaques that may be found in their brain," said R. Edward Coleman, M.D., professor of radiology, Duke University Medical Center. "This approval marks a great advancement in nuclear medicine practice, as it enables us to evaluate the presence or absence of moderate to frequent levels of amyloid plaques in a patient's brain. In conjunction with other tests, florbetapir may help give physicians additional information when evaluating patients for the cause of their cognitive decline."

Because Amyvid loses over half of its radioactivity every two hours, Amyvid must be distributed directly from a radiopharmacy to the imaging centers where it will be administered within several hours. Beginning in June, a limited number of radiopharmacies will be distributing Amyvid with the goal of making the product available in more areas as soon as possible.

"The approval of Amyvid exemplifies Lilly's commitment to discovering and developing innovative products for many of the world's unmet medical needs," said Alex Azar, president, Lilly USA. "We are working hard with our manufacturing partners to increase production of Amyvid and will notify the community as it becomes available in more markets."

Amyvid images should be interpreted only by readers who have successfully completed Amyvid reader training. Lilly has worked collaboratively with the FDA and nuclear medicine experts to identify the appropriate ways to support accurate and consistent interpretation of Amyvid scans by imaging physicians. These efforts resulted in the development and validation by Lilly of both an online and in-pe
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