Transcept resubmits NDA for first middle-of-the-night insomnia drug
This article was originally published in Scrip
Executive Summary
After completing a highway driving study requested by the US FDA and changing its packaging, Transcept Pharmaceuticals resubmitted its new drug application for its middle-of-the-night insomnia drug Intermezzo (zolpidem tartrate sublingual tablet). The drug had failed to win approval in October 2009.