NDA resubmitted for Intermezzo for insomnia
Transcept Pharmaceuticals announced that it has resubmitted its New Drug Application (NDA) to the FDA seeking approval of Intermezzo (zolpidem tartrate sublingual tablet) for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The Intermezzo resubmission package is intended to address issues raised in the October 2009 FDA Complete Response Letter. New information in the package includes data and analyses from the recently completed Intermezzo highway driving study, a comparative review of data from previous driving studies of sleep aids and other medications, and redesigned product packaging and instructional tools.
Zolpidem tartrate is an imidazopyridine hypnotic.
For more information call (510) 215-3500 or visit www.transcept.com.