Siemens’ PETNET Solutions Receives ANDA Approval for 18F Sodium Fluoride
· Company provides physicians and patients with access to the largest network of 18F NaF in the U.S.
· PET radiopharmaceutical indicated for bone imaging to define areas of altered osteogenic activity, including metastatic disease from cancer
Siemens’ PETNET Solutions, a wholly owned subsidiary of Siemens Healthcare, has received Abbreviated New Drug Application (ANDA) approval from the Food and Drug Administration (FDA) to manufacture and distribute the PET radiopharmaceutical sodium fluoride F 18 injection (18F NaF) across its entire national network of radiopharmacies, providing coverage to 99 percent of the U.S. population. 18F NaF is indicated for positron emission tomography (PET) bone imaging to define areas of altered osteogenic activity in the body, including metastatic bone disease from cancer. Multiple clinical studies have demonstrated improved sensitivity and specificity of PET/computed tomography (PET/CT) imaging compared to single-photon emission computed tomography (SPECT)/planar bone imaging.1-4 Early identification of patients at higher risk for developing bone metastases enables practitioners to be proactive in their diagnosis and treatment.5
With ANDA approval of 18F NaF throughout its national network of radiopharmacies, Siemens’ PETNET Solutions continues its longstanding support of 18F NaF PET in the molecular imaging community as well as its efforts to improve patient access. In 2009, Siemens’ PETNET Solutions supplied the American College of Radiology Imaging Network (ACRIN) with 18F NaF for its multi-center clinical trials. During the 2010 global molybdenum shortage that impacted access to SPECT bone scans, Siemens’ PETNET Solutions offered 18F NaF free of charge for a limited time to hospitals and imaging centers, helping to ensure patient access to metastatic bone disease evaluation via PET/CT bone scans.
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Siemens AG (Berlin and Munich) is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. The company is active in more than 200 countries, focusing on the areas of electrification, automation and digitalization. One of the world's largest producers of energy-efficient, resource-saving technologies, Siemens is No. 1 in offshore wind turbine construction, a leading supplier of combined cycle turbines for power generation, a major provider of power transmission solutions and a pioneer in infrastructure solutions as well as automation, drive and software solutions for industry. The company is also a leading provider of medical imaging equipment – such as computed tomography and magnetic resonance imaging systems – and a leader in laboratory diagnostics as well as clinical IT. In fiscal 2014, which ended on September 30, 2014, Siemens generated revenue from continuing operations of €71.9 billion and net income of €5.5 billion. At the end of September 2014, the company had around 357,000 employees worldwide. Further information is available on the Internet at http://www.siemens.com.
1Even-Sapir, E., Metser, U., Mishani, E., Lievshitz, G., et al. (2006). The Detection of Bone Metastases in Patients with High-Risk Prostate Cancer: 99mTc-MDP Planar Bone Scintigraphy, Single- and Multi-Field-of-Vew SPECT, 18F-Fluoride PET, and 18F-Fluoride PET/CT. J Nucl Med, 47(2), 287-97.
2Gerety, E.L., Lawrence, E.M., Wason, J., Yan, H., et.al. (2015). Prospective Study Evaluating the Relative Sensitivity of 18F-NaF PET/CT for Detecting Skeletal Metastases from Renal Cell Carcinoma in Comparison to Multidetector CT and 99m TC-MDP Bone Scintigraphy, Using an Adaptive Trial Design. Ann Oncol, Jul 22. pii: mdv289
3Schirrmeister, H., Guhlmann, A., Kotzerke, J., Santjohanser, C., et al. (1999). Early Detection and Accurate Description of Extent of Metastatic Bone Disease in Breast Cancer with Fluoride Ion and Positron Emission Tomography. J Clin Oncol, 17(8), 2381-9.
4Schirrmeister, H., Glatting, G., Hetzel, J., Nüssle, K., et al. (2001). Prospective Evaluation of the Clinical Value of Planar Bone Scans, SPECT, and 18F-Labeled NaF PET in Newly Diagnosed Lung Cancer. J Nucl Med, 42(12), 1800-4.
5Blum, R. H, Shasha, D., & Fleishman, S.B. (2003). The Multidisciplinary Approach to Bone Metastases. Cancer Network, http://www.cancernetwork.com/bone-metastases/multidisciplinary-approach-bone-metastases