Somaxon announced yesterday it will delay filing the NDA for Silenor until the first quarter of 2008. The company received a letter from the FDA stating the company must include transgenic mouse carcinogenicity data from an ongoing study. The agency wants Somaxon to provide the data in order to assess whether the sleeping drug could cause cancer. The company had originally planned to include the data after the NDA had been filed.
- see this release for more
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