Intermezzo FDA Approval History
FDA Approved: Yes (Discontinued) (First approved November 23, 2011)
Brand name: Intermezzo
Generic name: zolpidem tartrate
Dosage form: Sublingual Tablets
Company: Purdue Pharma LP
Treatment for: Insomnia
Marketing Status: Discontinued
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 timeline for Intermezzo
| Date | Article |
|---|
| Nov 23, 2011 | Approval 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 |
Further information
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