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Lilly Symbyax complete response

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly submits complete response during second quarter to an "approvable" letter for its olanzapine/fluoxetine combination Symbyax, the firm says July 24. Lilly "expects final FDA approval in 2004"; the NDA was submitted in fourth quarter 2002. The firm is highlighting the combo's rapid onset of action (1Pharmaceutical Approvals Monthly June 1, 2003, p. 5)...

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