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Knoll Meridia "approvable": diabetes use may be one topic of further discussion.

Executive Summary

KNOLL MERIDIA "APPROVABLE": LABELING DISCUSSIONS ON USE BY DIABETICS appear to be part of the dialogue between the sponsor and FDA, following the Nov. 8 determination that the weight-loss agent has reached the "approvable" stage. FDA arrived at its preliminary favorable decision on the user fee deadline date for action on the application (NDA 20-362).
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PS029187

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