January 20-21, 2011: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
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"On January 20, 2011, the committee will discuss new drug application (NDA) 202-008, florbetapir F 18 injection, sponsored by Avid Radiopharmaceuticals, Inc., proposed for use in positron emission tomography (PET) imaging of β-amyloid (beta-amyloid) aggregates in the brain to help rule out Alzheimer's disease.
"On January 21, 2011, the committee will discuss NDA 201-277, gadobutrol injection, sponsored by Bayer HealthCare Pharmaceuticals, proposed for use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity (abnormal blood supply and circulation) of the central nervous system. The BBB is an area consisting of specialized cells that restrict passage of certain molecules from the bloodstream into the brain."
Also, as background, from clinicaltrials.gov:
Phase III study of florbetapir F 18