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Ciltyri Approval Status

FDA Approved: No
Brand name: Ciltyri
Generic name: eplivanserin
Company: Sanofi
Treatment for: Insomnia

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 Status and FDA Approval Process for Ciltyri

DateArticle
Sep 17, 2009Sanofi-Aventis Receives Complete Response Letter from the FDA for eplivanserin (Ciltyri) Submission

Further information

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