FDA gives Combidex OK for lymph node imaging
Advanced Magnetics is halfway to an NDA approval for its MR contrast agent, Combidex. The FDA this month sent the company a letter saying that although it found Combidex approvable for its principal indication, as a lymph node imaging agent, it could not
Advanced Magnetics is halfway to an NDA approval for its MR contrast agent, Combidex. The FDA this month sent the company a letter saying that although it found Combidex approvable for its principal indication, as a lymph node imaging agent, it could not approve the agent for its secondary indication, imaging of the liver and spleen.
Jerome Goldstein, chairman and CEO of Advanced Magnetics, said his company should be able to meet the FDAs remaining conditions. Goldstein added that Combidex is the first lymph-node-specific MR contrast agent to be filed with the FDA.
The company has incurred financial losses waiting for approval to market this product. Advanced Magnetics showed a net loss this year of $1 million for the quarter ending March 31, compared to a net loss of $793,858 for the same period last year.
Advanced Magnetics develops MR contrast agents for the diagnosis of cancer and other diseases. The firm submitted its new drug application for Combidex to the FDA in December 1999. Advanced Magnetics European marketing partner, Guerbet, also submitted the European equivalent of an NDA to the European Medicines Evaluations Agency. Combidex is the third product Advanced Magnetics has developed (SCAN 5/24/00).