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Goal Finally In Sight For Shire's 'Adderall Beads' Extension Strategy

 
• By Sukaina Virji

Shire is set for a refiling of its NDA by the end of the year and a potential 2017 launch with its 'Adderall beads' for ADHD.

Shire reported positive topline results with SHP465 (triple-bead mixed amphetamine salts) in 275 adults aged 18-55 years with Attention-Deficit/Hyperactivity Disorder (ADHD), the last set of data required ahead of Class 2 Resubmission of an NDA with the US FDA by the end of 2016

The product is slated for potential US approval in the second half of 2017.

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