Tuesday, August 24, 2004 7:31:37 AM
In the United States, an approvable letter was received from the U.S. Food and Drug Administration for Combidex in June 2000. In June 2004, we announced that a response to the approvable letter was submitted to the FDA and that the FDA requested that we provide certain additional details underlying the existing supporting data in the submission in order to make the submission a complete response to the approvable letter."
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