Following up on a posting earlier this week: From a General Electrics press release 11 August 2009 FDA ADVISORY COMMITTEE RECOMMENDS DaTSCAN™ (Ioflupane I 123 Injection) PRINCETON, NJ--GE Healthcare announced today that the Peripheral and Central Nervous System Drugs advisory committee of the U.S. Food and Drug Administration (FDA) has voted to recommend DaTSCAN (Ioflupane I 123 Injection) to the FDA. The panel determined DaTSCAN has a favorable risk to benefit profile, voting 11 to two with one abstention. The proposed indication for DaTSCAN is for the visualization of the dopamine transporter (DaT) distribution within the striata by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration. In May 2009, the FDA accepted the New Drug Application and granted DaTSCAN priority review, a designation identified for areas of unmet medical need. If approved, DaTSCAN will be the first radiopharmaceut...
News about our knowledge of the brain and behavior
from Anthony Risser, Ph.D.