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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, 2011Approval FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep
Oct  7, 2011Transcept Pharmaceuticals Announces Intermezzo PDUFA Action Date of November 27, 2011
Sep 14, 2011Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration
Jul 15, 2011Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application
Jul 13, 2011Transcept Pharmaceuticals Expects Complete Response Letter on Intermezzo New Drug Application Based on Teleconference with FDA
Jan 19, 2011Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment of Middle of the Night Awakenings
Mar 25, 2010Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA
Feb 23, 2010Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review
Nov 24, 2009Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter
Oct 30, 2009Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application
Jun 11, 2009Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo
Dec 16, 2008Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo
Oct  1, 2008Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings

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