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Silenor FDA Approval History

FDA Approved: Yes (First approved March 17, 2010)
Brand name: Silenor
Generic name: doxepin
Dosage form: Tablets
Company: Somaxon Pharmaceuticals, Inc.
Treatment for: Insomnia

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.

Development timeline for Silenor

DateArticle
Mar 18, 2010Approval Somaxon Announces FDA Approval of Silenor (doxepin) for the Treatment of Insomnia
Jan 25, 2010Somaxon Provides Update on New Drug Application for Silenor for the Treatment of Insomnia
Dec 18, 2009Somaxon Scheduled to Meet with FDA to Discuss Complete Response Letter for Silenor NDA
Dec  7, 2009Somaxon Receives Complete Response Letter from the FDA for Silenor NDA
Jul  7, 2009Somaxon Announces $6 Million Private Equity Financing and Acceptance of NDA Resubmission of Silenor for the Treatment of Insomnia
Jun  5, 2009Somaxon Resubmits New Drug Application for Silenor (Doxepin) for the Treatment of Insomnia
Apr  7, 2009Somaxon Provides Update on New Drug Application for Silenor (doxepin) for the Treatment of Insomnia
Feb 27, 2009Somaxon Receives Complete Response Letter from the FDA for Silenor (doxepin)
Nov 24, 2008FDA Extends Review of Somaxon Pharmaceuticals' New Drug Application for Silenor (Doxepin) by up to Three Months
Apr 15, 2008Somaxon Pharmaceuticals Announces Acceptance for Filing of New Drug Application for Silenor for the Treatment of Insomnia
Jan 31, 2008Somaxon Pharmaceuticals Submits New Drug Application for Silenorfor the Treatment of Insomnia
May  9, 2007Somaxon Pharmaceuticals Provides Update on Silenor Development Program
Nov 20, 2006Somaxon Pharmaceuticals’ Silenor Demonstrates Positive Results in its Third Phase 3 Clinical Trial in Insomnia

See also

Silenor (doxepin) Consumer information

Further information

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