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FDA approves Siemens subsidiary's PET tracer

This article was originally published in Clinica

Executive Summary

PETNet Solutions, a subsidiary of imaging giant Siemens Healthcare, has received US approval for its PET tracer, Fludeoxyglucose (FDG) 18F Injection. Siemens Healthcare's Mark Palacio told Clinica that PETNet (Knoxville, Tennessee) is the first company to achieve approval of an abbreviated new drug application (ANDA) for FDG. 18F FDG is used to assess cancer patients for abnormal glucose metabolism, to assist in the evaluation of known or suspected abnormalities. It is also used in cardiology and neurology. The firm expects to see "significant benefits" in patient safety owing to "the tightly controlled manufacturing processes that are commensurate with an FDA-approved pharmaceutical". In fiscal year 2010, Siemens Healthcare posted revenue of €12.4bn and profit of around €750m.

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