FDA Rejects Favorable Vyvanse DEA Schedule: Time For Shire's 6 p.m. Theme
This article was originally published in Pharmaceutical Approvals Monthly
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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Shire's next-generation attention deficit/hyperactivity disorder drug Vyvanse (lisdexamfetamine dimesylate) clears FDA Feb. 23. The company will attempt to transition patients from Adderall XR to the new formulation before 2009, when Adderall generics are likely to launch. Vyvanse received a second "approvable" letter Dec. 21, but Shire had expected approval by March (1Pharmaceutical Approvals Monthly January 2007, p. 16). Indicated to treat children ages six to 12, the drug was evaluated in that age group in three dosage strengths (30 mg, 50 mg and 70 mg) in a 290-patient Phase III randomized, double-blind, placebo-controlled trial. Vyvanse is the first product to be approved following FDA's Feb. 21 announcement that manufacturers of 15 ADHD drugs would need to include patient medication guides to warn of possible cardiovascular and psychiatric risks...
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Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote
A new indication for the generic diuretic in heart failure with preserved ejection fraction gets an 8-4 vote, with one abstention, despite troubles an analysis that tries to revive the TOPCAT trial with an analysis excluding Eastern European sites – or about half the participants.