PET Imaging Agent Wins Approval in United States

a wholly-owned subsidiary of Siemens Medical Solutions USA, Inc. (Malvern, PA, USA), announced the approval of an Abbreviated New Drug Application (ANDA) for fluodeoxyglucose F18 Injection, United States Pharmacopeia (USP) ([18F]FDG). PETNET Solutions' submission of an ANDA, well in advance of regulatory requirements for the PET radiopharmaceutical industry, reinforces its investment in manufacturing and distribution of [18F]FDG. Siemens PETNET Solutions is the first commercial manufacturer and distributor to achieve approval of an ANDA for [18F]FDG.

"PETNET Solutions continues to set the standard in manufacturing and delivery of molecular imaging biomarkers,” said Ian Turner, CEO, Siemens PETNET Solutions. "US Food and Drug Administration [FDA] approval ensures our customers that they are receiving product that meets all regulatory and pharmacopeia requirements for safety, quality, and purity for [18F]FDG. This achievement is unique in the commercial PET radiopharmaceutical marketplace for [18F]FDG. We are committed to the highest level of quality manufacturing throughout our global network of production facilities. With the FDA approval of our ANDA for [18F]FDG, we continue to demonstrate an enduring commitment to leadership in the US market for PET radiopharmaceuticals.”

This milestone comes in parallel with PETNET Solutions' significant investments to increase its radiopharmaceutical manufacturing and distribution capabilities worldwide, and lays the foundation for quality manufacturing of new molecular imaging biomarkers as they are commercialized. PETNET Solutions operates the largest network of PET radiopharmaceutical production facilities with 54 production and distribution centers worldwide.

[18F]FDG is used in oncology for the evaluation of abnormal glucose metabolism to assist in the evaluation of known or suspected abnormalities; in cardiology, when used together with myocardial perfusion imaging to aid in identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction; and in neurology, for the identification of regions of abnormal glucose metabolism associated with epileptic seizure foci.

Because radiation-emitting products including [18F]FDG may increase the risk for cancer, particularly in pediatric patients, the smallest dose necessary for imaging should be used. In the oncology and neurology environments, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels; medical therapy and lab testing may be used to assure at least two days of normal levels prior to [18F]FDG administration. Hypersensitivity reactions with pruritus (itching), edema, and rash have been reported; therefore, emergency resuscitation equipment and personnel should be available.

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