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Vyvanse Approval History

  • FDA approved: Yes (First approved February 23rd, 2007)
  • Brand name: Vyvanse
  • Generic name: lisdexamfetamine dimesylate
  • Company: Shire plc/New River Pharmaceuticals
  • Treatment for: ADHD

Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Vyvanse was developed to lower abuse potential by remaining therapeutically inactive until metabolized in the body.

FDA Approval History for Vyvanse

DateArticle
Feb  7, 2012Approval Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD
Nov 15, 2010Approval FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents
Jun  1, 2009Approval FDA Approves Labeling Change for Vyvanse (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD
Apr 23, 2008Approval FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
Jan  3, 2008Approval FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians Tailor Treatment for Individual Patients
Feb 26, 2007Approval Shire Receives FDA Approval of Vyvanse for ADHD
Dec 21, 2006New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse
Oct  6, 2006FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD
Jan 27, 2006New River Pharmaceuticals Announces NRP104 NDA Accepted for Review
Dec  7, 2005Shire Announces New River Pharmaceuticals Filing of NRP104

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