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Somaxon’s Silenor Could Launch In Early ’09 Pending Partnering Discussions

This article was originally published in The Pink Sheet Daily

Executive Summary

Somaxon submits an NDA for the insomnia medication, setting it up for potential FDA approval in December, firm tells "The Pink Sheet" DAILY.

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Back In The Game: One Year After Rx Exit, P&G Signs On To Promote Silenor

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Back In The Game: One Year After Rx Exit, P&G Signs On To Promote Silenor

Somaxon and P&G are preparing to launch the insomnia drug in September with a combined sales force of 215 reps.

Silenor "Complete Response" Letter Hints At Efficacy Issues

Somaxon's last-minute conference call announcing FDA's "complete response" letter for the insomnia agent Silenor (doxepin) did little to clarify whether the agency's concerns have to do with efficacy issues or whether FDA just wants more data on doxepin's potential to prolong the QT interval. Somaxon announced the action letter late on Feb. 26

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