Regulatory Actions
Sanofi-Aventis Receives Complete Response Letter from the FDA for Eplivanserin (Ciltyri(R)) Submission
Published in Medical Letter on the CDC and FDA, October 4th, 2009
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.
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