MRI contrast developer Advanced Magnetics said that its European partner Guerbet has filed a marketing authorization application (MAA) with the European Agency for the Evaluation of Medicinal Products (EMEA) for its Combidex functional MRI agent.
Guerbet of Roissy, France, is seeking clearance for the agent under the trade name Sinerem as an aid in differentiating lymph nodes in patients with pelvic cancers, including prostate, bladder, and uterine cancer, according to Advanced Magnetics of Cambridge, MA. The MAA will be reviewed by the U.K. and Ireland, and subject to approval in Europe.
Guerbet plans to launch Sinerem in Germany and the U.K. during the second quarter of 2008, and plans to file an application in Switzerland by the end of 2006, according to Advanced Magnetics.
By AuntMinnie.com staff writers
December 6, 2006
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