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Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate, is a sublingual low dose formulation of zolpidem that has been developed for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. On September 30, 2008, Transcept submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval to market Intermezzo® in the United States. The FDA issued a Complete Response Letter regarding the New Drug Application for Intermezzo® on October 28, 2009, and Transcept is working to respond to the issues raised in the Complete Response Letter.
Recent & Upcoming Events
08/09/10 Transcept Second Quarter 2010 Earnings Conference Call
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Stock Information
NASDAQ:TSPT $7.54
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09/03/10 4:00 PM ET |
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