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
You may also be interested in...
Somaxon's Silenor Gains An FDA Approval, But Can The Pharma Afford A Launch?
Somaxon hopes to launch its insomnia drug in the second half of 2010, but is still searching for a U.S. commercial partner.
Transcept's Intermezzo Yields To FDA Concerns Over Residual Side Effects
Transcept's low-dose zolpidem for middle-of-the-night awakenings may need additional studies, including driving tests.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011