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Transcept Aims To Refile Intermezzo Insomnia NDA With Highway Driving Data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA approved a resubmission plan for Transcept Pharmaceuticals' insomnia drug Intermezzo that involves new packaging to foil inadvertent re-dosing and a next-day highway driving study to satisfy concerns the agency raised in a "complete response" letter, the company said March 24. The filing is targeted for late in the fourth quarter

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