Neuroscience
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 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.
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Neuroscience
FDA: Datscan: A Radiopharmaceutical and Parkinson Disease
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 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.
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From The New York Times: F.D.A. Sees Promise in Alzheimer’s Imaging Drug By THE ASSOCIATED PRESS Published: January 20, 2011 Filed at 5:40 p.m. ESTWASHINGTON (AP) — A federal panel of medical experts said Thursday a first-of-a-kind imaging chemical...
- Neuropsychology Abstract Of The Day: Parkinson's Disease And Olfaction
Landis BN & Burkhard PR. Phantosmias and Parkinson disease. Archives of Neurology. 2008 Sep; 65(9): 1237-1239. BACKGROUND: Impaired olfaction is a common, nonmotor manifestation of Parkinson disease (PD). However, to our knowledge, qualitative olfactory...
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From The Washington Post: Use of Drug to Treat ADHD in Children Opposed Associated Press Friday, March 24, 2006; Page A11 The narcolepsy drug modafinil should not be approved as a treatment for attention-deficit hyperactivity disorder in children until...
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