Silenor Approval History 
Silenor (doxepin) is a low-dose oral tablet
formulation of the H1 receptor antagonist doxepin indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.
FDA Approval History for Silenor
| Date | Article |
|---|
| Mar 18, 2010 |  Somaxon Announces FDA Approval of
Silenor (doxepin) for the Treatment of Insomnia |
| Jan 25, 2010 | Somaxon Provides Update on New Drug Application for Silenor for the Treatment of Insomnia |
| Dec 18, 2009 | Somaxon Scheduled to Meet with FDA to Discuss Complete Response Letter for Silenor NDA |
| Dec 7, 2009 | Somaxon Receives Complete Response Letter from the FDA for Silenor NDA |
| Jul 7, 2009 | Somaxon Announces $6 Million Private Equity Financing and Acceptance of NDA Resubmission of Silenor for the Treatment of Insomnia |
| Jun 5, 2009 | Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia |
| Apr 7, 2009 | Somaxon Provides Update on New Drug Application for Silenor (doxepin) for the Treatment of Insomnia |
| Feb 27, 2009 | Somaxon Receives Complete Response Letter from the FDA for Silenor (doxepin) |
| Nov 24, 2008 | FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months |
| Apr 15, 2008 | Somaxon Pharmaceuticals Announces Acceptance for Filing of New Drug
Application for Silenor for the Treatment of Insomnia |
| Jan 31, 2008 | Somaxon Pharmaceuticals Submits New Drug Application for Silenor
for the Treatment of Insomnia |
| May 9, 2007 | Somaxon Pharmaceuticals Provides Update on Silenor Development
Program |
| Nov 20, 2006 | Somaxon Pharmaceuticals’ Silenor Demonstrates Positive Results in its Third Phase 3 Clinical Trial in Insomnia |
See also...
Silenor (doxepin) Consumer Information
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