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Intuniv Approval History

  • FDA approved: Yes (First approved September 2nd, 2009)
  • Brand name: Intuniv
  • Generic name: guanfacine
  • Previous name: Connexyn
  • Company: Shire plc
  • Treatment for: ADHD

Intuniv (guanfacine) is a nonstimulant selective alpha-2A-receptor agonist for the treatment of children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

FDA Approval History for Intuniv

DateArticle
Sep  3, 2009Approval Shire Announces FDA Approval of Once-Daily Intuniv (guanfacine) Extended Release Tablets for the Treatment of ADHD in Children and Adolescents Aged 6 to 17
Jul 28, 2009FDA Issues Complete Response Letter for Intuniv (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents
Jun 21, 2007Shire Receives Approvable Letter From FDA for Intuniv (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD
Aug 24, 2006Shire Announces NDA Submission of Guanfacine Extended Release for the Treatment of ADHD in Children and Adolescents

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