Contrast agent developer Advanced Magnetics of Cambridge, MA, has received an approvable letter from the Food and Drug Administration for its Combidex MRI agent, the company reported today.
The FDA issued the letter for the primary indication of Combidex, as a lymph node imaging agent. Advanced Magnetics hoped that Combidex would also be approved for the secondary indications of liver and spleen imaging, but the FDA determined that the agent is not approvable for those uses at this time.
Final FDA approval is subject to conditions stipulated by the FDA, according to Advanced Magnetics. The company believes that Combidex is the first lymph-node-specific MRI contrast agent to be reviewed by the FDA.
By AuntMinnie.com staff writersJune 22, 2000
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