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Shire submits Connexyn for ADHD

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire submitted an NDA Aug. 24 for its attention deficit/hyperactivity disorder compound SPD503 (guanfacine) with the proposed trade name Connexyn. If approved, the drug would be the second non-stimulant product in its category. The company submitted another ADHD drug in July - SPD465 - designed to provide sustained release of medication for 16 hours. SPD465 has a May 21, 2007 standard review user fee date for treatment of adult ADHD; the agent has the same active ingredient as Shire's established Adderall brand (1Pharmaceutical Approvals Monthly August 2006, In Brief)...

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