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Intermezzo

Update: Intermezzo (zolpidem tartrate sublingual tablets) Now FDA Approved - November 23, 2011

Transcept Pharmaceuticals Announces Intermezzo PDUFA Action Date of November 27, 2011

POINT RICHMOND, Calif., Oct. 4, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has notified the company that it has classified the recent Intermezzo New Drug Application (NDA) resubmission as a complete Class 1 response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of November 27, 2011 for the completion of the NDA review.

About Transcept

Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience. Transcept is developing Intermezzo® (zolpidem tartrate sublingual tablet) as a prescription sleep aid for use as needed when a middle of the night awakening is followed by difficulty returning to sleep. Transcept and Purdue Pharmaceutical Products L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States. Transcept is also developing TO-2061, a low dose ondansetron augmentation therapy for patients with obsessive compulsive disorder (OCD) who have not adequately responded to treatment with approved first-line pharmacotherapy.

Contact:

Transcept Pharmaceuticals, Inc.
Greg Mann
Director, Corporate Communications
(510) 215-3567

Posted: October 2011

Related Articles

• FDA Approves Intermezzo for Middle-of-the-Night Waking Followed by Difficulty Returning to Sleep - November 23, 2011
• Transcept Pharmaceuticals Announces Plan to Resubmit Intermezzo New Drug Application Following Meeting with the U.S. Food & Drug Administration - September 14, 2011
• Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - July 15, 2011
• Transcept Pharmaceuticals Expects Complete Response Letter on Intermezzo New Drug Application Based on Teleconference with FDA - July 13, 2011
• Transcept Pharmaceuticals Resubmits Intermezzo New Drug Application for the Treatment of Middle of the Night Awakenings - January 19, 2011
• Transcept Pharmaceuticals Updates Plan for Intermezzo NDA Resubmission Following Teleconference With the FDA - March 25, 2010
• Transcept Pharmaceuticals Provides Update on Intermezzo Regulatory Review - February 23, 2010
• Transcept Pharmaceuticals Scheduled to Meet With FDA to Discuss Intermezzo Complete Response Letter - November 24, 2009
• Transcept Pharmaceuticals Receives Complete Response Letter from FDA on Intermezzo New Drug Application - October 30, 2009
• Transcept Pharmaceuticals Announces Expected FDA Extension of Regulatory Review Period for Intermezzo - June 11, 2009
• Transcept Pharmaceuticals Announces FDA Acceptance for Review of New Drug Application for Intermezzo - December 16, 2008
• Transcept Pharmaceuticals Submits New Drug Application for Intermezzo for Treatment of Middle-of-the-Night Awakenings - October 1, 2008

Intermezzo (zolpidem tartrate) FDA Approval History