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news.Transcept Pharmaceuticals has informed regarding the refiling of the new drug application (NDA) of Intermezzo (zolpidem tartrate sublingual tablet) with the US Food and Drug Administration (FDA).
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Intermezzo is indicated for the treatment of insomnia or sleeping disorders.
The refiling of the application follows a meeting between Transcept and the FDA, to discuss the issues raised by the FDA in July 2011 Complete Response Letter.