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)...