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Sanofi Seeks Further FDA Input Following Zimulti NDA Withdrawal

Executive Summary

Sanofi-Aventis intends to resubmit its NDA for Zimulti (rimonabant) pending clarification of FDA's questions regarding its obesity claim. The firm announced it was withdrawing the application June 29, roughly two weeks after the agency's Endocrinologic and Metabolic Drugs Advisory Committee unanimously voted against approval of the cannabinoid-1 receptor antagonist for weight loss

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