Vyvanse FDA Approval History
FDA Approved: Yes (First approved February 23, 2007)
Brand name: Vyvanse
Generic name: lisdexamfetamine dimesylate
Dosage form: Capsules
Company: Shire plc
Treatment for: ADHD
Vyvanse (lisdexamfetamine dimesylate) is an amphetamine derivative prodrug administered once-daily for the treatment of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder.
Development timeline for Vyvanse
Date | Article |
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Jan 30, 2015 | Approval FDA Expands Uses of Vyvanse to Treat Binge-Eating Disorder |
Feb 7, 2012 | Approval Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) Now Approved in the US for Maintenance Treatment in Adults with ADHD |
Nov 15, 2010 | Approval FDA Approves Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the Treatment of ADHD in Adolescents |
Jun 1, 2009 | Approval 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, 2008 | Approval FDA Approves Vyvanse (lisdexamfetamine dimesylate), the First and
Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults |
Jan 3, 2008 | Approval FDA Approves Additional Dosage Strengths of Shire's ADHD Treatment
Vyvanse (lisdexamfetamine dimesylate) Which May Help Physicians
Tailor Treatment for Individual Patients |
Feb 26, 2007 | Approval Shire Receives FDA Approval of Vyvanse for ADHD |
Dec 21, 2006 | New River Pharmaceuticals and Shire Receive Approvable Letter for Vyvanse |
Oct 6, 2006 | FDA Issues Approvable Letter for NRP104 (lisdexamfetamine dimesylate) for the Treatment of ADHD |
Jan 27, 2006 | New River Pharmaceuticals Announces NRP104 NDA Accepted for Review |
Dec 7, 2005 | Shire Announces New River Pharmaceuticals Filing of NRP104 |
Further information
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