MR contrast developer Advanced Magnetics of Cambridge, MA, reported that it has received an approvable letter from the Food and Drug Administration regarding Combidex, its investigational functional molecular imaging agent.
The FDA requested additional data demonstrating the efficacy of Combidex, according to the company. The agency indicated that its principal issues relate to the topics addressed by its Oncologic Drugs Advisory Committee on March 3 this year, primarily how data submitted by the firm could be generalized across all tumor types.
Advanced Magnetics said the FDA suggested that the data be limited to a well-defined population of specific cancer types, and that the agency was willing to work with the company on how to address the issues it had raised.
By AuntMinnie.com staff writers
March 24, 2005
Related Reading
U.S. panel rejects Advanced Magnetics imaging agent, March 4, 2005
Combidex gets FDA review date, February 1, 2005
Advanced Magnetics boosts sales, losses in Q1, January 18, 2005
Advanced Magnetics, Cytogen get FDA nod, October 20, 2004
Advanced Magnetics post Q3 loss, July 19, 2004
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