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 radiopharmaceutical agent available to detect DaT distribution within the brain.
“We are pleased that the committee has recognized the potential benefit of DaTSCAN,” said Don Black, MD, head of R&D for GE Healthcare Medical Diagnostics. “Making DaTSCAN available in the U.S. would be an important milestone for GE Healthcare and improved patient care.”
The Prescription Drug User Fee Act (PDUFA) date for DaTSCAN is September 9, 2009.
DaTSCAN has been available in Europe since 2000 and has been used in more than 200,000 patients in 32 countries. It has been administered to nearly 1,000 patients in clinical trials.
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GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.
Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.