Brain amyloid imaging - FDA approval of florbetapir F18 injection

New England Journal of Medicine

Volumn 367, Issue 10, 2012, Pages 885-887

  Yang, Lucie ^a   Rieves, Dwaine ^a   Ganley, Charles ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMYLOID; AMYLOID BETA PROTEIN; AMYVID; FLORBETAPIR F 18; UNCLASSIFIED DRUG;

ALZHEIMER DISEASE; AUTOPSY; BRAIN HOMOGENATE; BRAIN LEVEL; COGNITIVE DEFECT; DIAGNOSTIC ACCURACY; DIAGNOSTIC ERROR; DIAGNOSTIC VALUE; DRUG APPROVAL; DRUG PROTEIN BINDING; FOOD AND DRUG ADMINISTRATION; GRAY MATTER; HUMAN; IMAGE ANALYSIS; INTERRATER RELIABILITY; MEDICAL EDUCATION; MILD COGNITIVE IMPAIRMENT; NEUROIMAGING; NEUROPATHOLOGY; PATHOPHYSIOLOGY; POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; PROGNOSIS; PROTEIN AGGREGATION; PROTEIN ANALYSIS; SENILE PLAQUE; SENSITIVITY AND SPECIFICITY; SHORT SURVEY; TERMINALLY ILL PATIENT; WHITE MATTER;

EID: 84865683216     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMp1208061     Document Type: Article

References (5)

1. Promoting brain health. Atlanta: Centers for Disease Control and Prevention, 2011 (http://www.cdc.gov/aging/pdf/cognitive-impairment/cogImp- genAud-final.pdf).
2. Highlights of prescribing information: Amyvid (florbetapir F18 injection). Silver Spring, MD: Food and Drug Administration (http://www. accessdata.fda.gov/drugsatfda-docs/label/2012/202008s000lbl.pdf).
3. Okie S. Confronting Alzheimer's disease. N Engl J Med 2011;365:1069-72.
4. Lister-James J, Pontecorvo MJ, Clark C, et al. Florbetapir F-18: a histopathologically validated beta-amyloid positron emission tomography imaging agent. Semin Nucl Med 2011;41:300-4.
5. Guidance for industry: developing medical imaging drug and biological products. Part 2: clinical indications. Washington, DC: Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, 2004 (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM071603.pdf).