FDA Asks Sanofi-Aventis for More Information on Insomnia Drug Eplivanserin
Thu, 09/17/2009 - 4:44am
NEW YORK (AP) — Sanofi-Aventis SA said Wednesday it received a letter from the Food and Drug Administration requesting more information about the company's chronic insomnia treatment Eplivanserin before it can be approved. Sanofi-Aventis said the FDA asked for further detail on the drug candidate's risk-benefit profile. The company said it will contact the FDA within the coming days to request a meeting to discuss what steps and data would be needed for approval.