DaTscanTreatment for Diagnostic
Update: DaTscan Now FDA Approved - January 14, 2011
DaTSCAN NDA Accepted for Priority Review
GE Healthcare's Application for DaTSCAN (Ioflupane I123 Injection) Accepted by the FDA for Priority Review
PRINCETON, N.J.--(BUSINESS WIRE)--Jun 2, 2009 - GE Healthcare announced today that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for DaTSCAN (Ioflupane I123 Injection) for priority review. DaTSCAN is a radiopharmaceutical agent containing Ioflupane (¹²³I) in development for a proposed indication of the detection of loss of functional nigrostraiatal dopaminergic neurons by single photon emission computed tomography (SPECT) imaging in patients presenting with symptoms or signs suggestive of dopaminergic neurodegeneration.
A priority review designation is intended for drugs that offer major advances in treatment, or provide treatment where no adequate therapy exists. The FDA's goal is to review and act on 90 percent of NDAs designated as priority review within six months of receipt.
"We are very pleased that the FDA has accepted our NDA for DaTSCAN," said Don Black, MD, head of R&D for GE Healthcare Medical Diagnostics. "Acceptance of the NDA filing for priority review is an important milestone for GE Healthcare, and we will continue to work with the FDA with the objective of making DaTSCAN available in the United States."
DaTSCAN has been available in Europe since 2000. In Europe, DaTSCAN is indicated for detecting loss of functional dopaminergic neuron terminals in the striatum in patients with clinically uncertain Parkinsonian Syndromes in order to help differentiate Essential Tremor from Parkinsonian Syndromes related to idiopathic Parkinson's Disease (PD), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP). DaTSCAN is unable to discriminate between PD, MSA and PSP. In Europe, it is also indicated to help differentiate probable dementia with Lewy bodies (DLB) from Alzheimer's disease. DaTSCAN is unable to discriminate between DLB and Parkinson's disease dementia.
About GE Healthcare
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.
Contact: GE Healthcare
Posted: June 2009
- FDA Approves DaTscan (Ioflupane I 123 Injection) for Visualization of Dopamine Transporters in Patients with Suspected Parkinsonian Syndromes - January 18, 2011