MR contrast developer Advanced Magnetics of Cambridge, MA, and biopharmaceutical firm Cytogen of Princeton, NJ, said they have submitted a complete response to the approvable letter received from the Food and Drug Administration for Combidex, Advanced Magnetics' investigational molecular imaging agent.
The September 30 submission has been accepted by the FDA and assigned a user-fee goal date of March 30, 2005, according to the companies. The Combidex product received an approvable letter from the FDA, subject to certain conditions, in June of 2000, and those conditions have now been met, they said.
By AuntMinnie.com staff writers
October 20, 2004
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