FDA Approvals of 2012

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Choline C 11

Drug: Choline C 11 Injection
Generic molecule: Choline
Organization: Mayo Clinic PET Radiochemistry Facility
Approval date: Sept. 12

The scoop: In September, the Mayo Clinic became the first facility approved to manufacture the Choline C 11 injection, a PET imaging agent used in detecting recurring prostate cancer. The injection helps produce an image that is useful in locating testing sites in the body for signs of cancer. Although PET imaging is not considered a replacement for tissue sampling and testing, but it may reveal signs that cancer has returned when other more conventional imaging doesn't.