Transcept resubmits NDA for Intermezzo.
M2 PHARMA-September 29, 2011-Transcept resubmits NDA for Intermezzo(C)2011 M2 COMMUNICATIONS
29 September 2011 - US Transcept Pharmaceuticals Inc (NASDAQ:TSPT) said on Tuesday it had resubmitted to the US Food and Drug Administration (FDA) the New Drug Application (NDA) for Intermezzo (zolpidem tartrate sublingual tablet).
The company is developing Intermezzo as a prescription sleep aid for use as needed when a middle of the night awakening is followed by difficulty returning to sleep.
The resubmission follows a meeting between Transcept and the agency on 14 September 2011 to discuss issues raised by the FDA in the July 2011 Complete Response letter.
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|Date:||Sep 29, 2011|
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