Biovail NDA For New Wellbutrin Formulation Is “Not Approvable”
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA had concerns over design of pharmacokinetic studies of once-daily salt formulation of bupropion for depression, the firm says.
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More Depressing News For Biovail: Decision On New Wellbutrin Formula Six Months Away
Agency has designated Biovail’s complete response to a “not approvable” letter as a class 2 review, giving application an April 23, 2008, action date, as opposed to a class 1 review, which would take only two months.