 |
UPDATE - New Fludeoxyglucose F 18
Injection PET
Drug Approved in Less than 6 Months
On August 5, 2004, the Food and Drug Administration (FDA)
approved a new drug application (NDA) for Fludeoxyglucose F 18
Injection ([18F]FDG) submitted by Weill Medical College of Cornell
University, Citigroup Biomedical Imaging Center. The NDA was
approved according to the streamlined procedures outlined in a March
2000 guidance on the approval of positron emission tomography (PET)
drugs. The Weill Medical College application was approved in less
than 6 months. Although approved applications are not yet required
for PET drugs, FDA encourages PET centers to submit applications for
approval and is committed to working closely with applicants during
the drug approval process.
[18F]FDG is a positron emission tomography (PET) drug used in
diagnostic imaging. On March 10, 2000, FDA announced [18F]FDG to be
safe and effective for certain indications when produced under
conditions specified in approved applications (see Federal Register,
Vol. 65, No. 48, 12999-13010). In accordance with the Food and Drug
Administration Modernization Act of 1997, FDA developed a draft
guidance for industry entitled PET Drug Applications – Content and
Format for NDA’s and ANDA’s (www.fda.gov/cder/regulatory/pet).
This guidance outlines a simplified process that PET producers can
use to demonstrate that their drug meets quality standards. Weill
Medical College of Cornell University, Citigroup Biomedical Imaging
Center in New York City submitted the NDA in response to the FDA
announcements.
[18F]FDG is indicated in positron emission tomography (PET) imaging
for (1) assessment of abnormal glucose metabolism to assist in the
evaluation of malignancy in patients with known or suspected
abnormalities found by other testing modalities, or in patients with
an existing diagnosis of cancer; (2) patients with coronary artery
disease and left ventricular dysfunction, when used together with
myocardial perfusion imaging, for the identification of left
ventricular myocardium with residual glucose metabolism and
reversible loss of systolic function; and (3) patients for the
identification of regions of abnormal glucose metabolism associated
with foci of epileptic seizures.
 Back
to Top 
Back to PET
Date created: August 6, 2004 |
|
