Vyvanse’s Long Shadow: Launch To Decide Fate Of Two Other Shire NDAs
This article was originally published in Pharmaceutical Approvals Monthly
Shire is keeping two pending NDAs for new attention deficit hyperactivity disorder treatments in a sort of limbo while it waits to see if the high expectations for the launch of its d-amphetamine prodrug Vyvanse are fulfilled
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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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