Sanofi-Aventis receives complete response letter from the FDA for Ciltyri

BRIDGEWATER, N.J. Sanofi-Aventis said that the Food and Drug Administration has issued a complete response letter regarding the company's new drug application for Ciltyri (eplivanserin).

The drug was reviewed as a potential treatment for patients with chronic insomnia characterized by difficulties with sleep maintenance.

Sanofi-Aventis is currently reviewing the content of the complete response letter, in which the FDA has requested additional information regarding benefit-risk. The company will contact the FDA in the coming days to request a meeting to discuss what steps and data would be needed for approval.