Ciltyri FDA Approval Status
Ciltyri (eplivanserin) is a serotonin type 2 A receptor antagonist intended for use in patients with chronic insomnia characterized by difficulties with sleep maintenance.
In September 2009, Sanofi-Aventis announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for Ciltyri (eplivanserin) had not been approved.
Development Timeline for Ciltyri
|Sep 17, 2009||Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission|
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