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FDA approvable letter for contrast agent Combidex:

Advanced Magnetics has received an approvable letter from the US FDA for its MRI contrast agent, Combidex, in its principal indication as a lymph node imaging agent, but additional indications of liver and spleen imaging were not deemed approvable at this time. The Cambridge, Massachusetts-based company told Clinica that as it already markets Feridex IV for liver and spleen imaging it would not be carrying out further trials of Combidex in these indications.

Advanced Magnetics has received an approvable letter from the US FDA for its MRI contrast agent, Combidex, in its principal indication as a lymph node imaging agent, but additional indications of liver and spleen imaging were not deemed approvable at this time. The Cambridge, Massachusetts-based company told Clinica that as it already markets Feridex IV for liver and spleen imaging it would not be carrying out further trials of Combidex in these indications.

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