GE Healthcare Announces Acceptance of Applications for Review of Investigational Imaging Agent [18F]Flutemetamol in the United States and Europe
1/8/2013 9:41:23 AM
PRINCETON, N.J.--(BUSINESS WIRE)--GE Healthcare today announced that regulatory bodies in the United States and Europe have accepted its applications for review of the investigational PET amyloid imaging agent [18F]flutemetamol, a positron emission tomography (PET) imaging agent. A New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) for [18F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) or other cognitive disorders. Additionally, a Marketing Authorisation Application (MAA) was submitted to the European Medicines Agency for [18F]flutemetamol use in the visual detection of beta amyloid in the brains of adult patients who are being evaluated for AD.