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Sanofi-Aventis’ Ambien CR “Approvable” At FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

Sanofi-Aventis' controlled-release formulation of its insomnia agent zolpidem, Ambien CR, received an FDA "approvable" letter, the company announced April 11

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Takeda's Rozerem Will Not Be First-Line Competitor To Ambien, Sanofi Says

Rozerem (ramelteon) launch could open a new segment of sleep aid market; Sanofi-Aventis predicts the insomnia agent's different mechanism of action will prevent it from competing directly with Ambien. Company is readying launch of Ambien CR to counter increased competition.

Takeda's Rozerem Will Not Be First-Line Competitor To Ambien, Sanofi Says

Rozerem (ramelteon) launch could open a new segment of sleep aid market; Sanofi-Aventis predicts the insomnia agent's different mechanism of action will prevent it from competing directly with Ambien. Company is readying launch of Ambien CR to counter increased competition.

Sanofi-Aventis Eyes Summer Launch For Ambien CR

Discussions with FDA following an "approvable" letter for the sleep therapy have revolved around labeling for treatment duration, the company says. A summer launch would put Ambien CR's introduction several months behind that of Sepracor's Lunesta, which entered the insomnia market in early April.

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