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TSPT: To Meet w/FDA on Jan. 30 re NDA Letter for Intermezzo(R)

Posted on: Tue, 24 Nov 2009 10:43:00 EST

Symbols: TSPT

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Ridgeland, MS, NOV 24, 2009 (EventX/Knobias.com via COMTEX) --
TSPT | Quote | Chart | News | PowerRating -- By Fain Hughes, fhughes@knobias.com

Transcept Pharmaceuticals, Inc. (TSPT) announced that it is scheduled to meet with the U.S. FDA on January 20, 2010 to discuss the Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo(R)(zolpidem tartrate sublingual tablet). The Complete Response Letter, received by Transcept on October 28, 2009, indicated that the FDA could not approve the NDA in its present form. The NDA seeks approval to market Intermezzo(R) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.

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For full details on Transcept Pharmaceuticals Inc (TSPT) TSPT. Transcept Pharmaceuticals Inc (TSPT) has Short Term PowerRatings at TradingMarkets. Details on Transcept Pharmaceuticals Inc (TSPT) Short Term PowerRatings is available at This Link.

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