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Transcept Pharmaceuticals, Inc.
TSPT today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval of Intermezzo® for use as needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep.
Transcept expects that the Intermezzo® NDA resubmission, if accepted and deemed complete by the FDA, will be subject to a Class 2 six-month review.
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