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 sodium fluoride F-18 (F-18 NaF) radiopharmaceutical.
The company said it can now manufacture and distribute the F-18 NaF injection across its national network of radiopharmacies.
F-18 NaF is used for bone imaging with PET to define areas of altered osteogenic activity, including metastatic bone disease. Clinical studies have shown improved sensitivity and specificity with PET/CT compared to SPECT planar bone imaging, Siemens said.
