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Article: Sanofi-Aventis Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri(R)) Submission.
- Article from:
- PR Newswire
- Article date:
- September 16, 2009
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BRIDGEWATER, N.J., Sept. 16 /PRNewswire-FirstCall/ -- Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the company's New Drug Application (NDA) for eplivanserin (Ciltyri ). Eplivanserin 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 ...