Siemens Healthcare subsidiary PETNet Solutions has received approval from the U.S. Food and Drug Administration (FDA) for an abbreviated new drug application (ANDA) for its F-18 FDG injection.
PETNet Solutions is the first commercial manufacturer and distributor to achieve approval of an ANDA for F-18 FDG, the firm said.
FDG is used in oncology to assess abnormal glucose metabolism in the evaluation of known or suspected abnormalities, according to the company. In cardiology, it is used with myocardial perfusion imaging to help identify left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction.
In neurology, FDG helps detect regions of abnormal glucose metabolism associated with epileptic seizure foci, PETNet said.
