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FDA Rejects Favorable Vyvanse DEA Schedule: Time For Shire's 6 p.m. Theme

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA disagreed with New River Pharmaceuticals (now Shire) on the abuse liability of the d-amphetamine prodrug Vyvanse, forcing the sponsor to change its message from abuse protection to duration of effect - a secondary endpoint in pivotal trials that was not a notable issue in FDA's review of the pediatric attention deficit hyperactivity disorder NDA.

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