Intermezzo Approval History
- FDA approved: Yes (First approved November 23rd, 2011)
- Brand name: Intermezzo
- Generic name: zolpidem tartrate
- Dosage form: Sublingual Tablets
- Company: Transcept Pharmaceuticals, Inc.
- Treatment for: Insomnia
Intermezzo is a low dose, fast acting, sublingual formulation of the hypnotic agent zolpidem, indicated for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep.
Development History and FDA Approval Process for Intermezzo
|Nov 23, 2011|| FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep|
|Oct 7, 2011||Transcept Pharmaceuticals Announces Intermezzo PDUFA Action Date of November 27, 2011|
|Sep 14, 2011||Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration|
|Jul 15, 2011||Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application|
|Jul 13, 2011||Transcept Pharmaceuticals Expects Complete Response Letter on Intermezzo New Drug Application Based on Teleconference with FDA|
|Jan 19, 2011||Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment of Middle of the Night Awakenings|
|Mar 25, 2010||Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA|
|Feb 23, 2010||Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review|
|Nov 24, 2009||Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter|
|Oct 30, 2009||Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application|
|Jun 11, 2009||Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo|
|Dec 16, 2008||Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo|
|Oct 1, 2008||Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings|
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