NDA 21977, held by Takeda Pharms USA. Lisdexamfetamine Dimesylate.
As of Nov 15, 2026, NDA 21977 (Vyvanse), held by Takeda Pharms USA, was first approved by FDA on Feb 23, 2007, with 43 approved supplements and 0 published complete response letters.
VYVANSE is indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Moderate to severe binge eating disorder (BED) in adults.
| Jul 29, 2021 | Supplement 46Efficacy (new indication or use) · Priority review | Approved | |
| Oct 14, 2016 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Jan 30, 2015 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | |
| Apr 26, 2013 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2012 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2010 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Apr 5, 2010 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| May 22, 2009 | Supplement 7Efficacy (new indication or use) | Approved | |
| Apr 23, 2008 | Supplement 1Efficacy (new indication or use) | Approved | |
| Feb 23, 2007 | Original applicationNew molecular entity · Standard review | Approved |
| Vyvanse30MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Vyvanse50MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Vyvanse70MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Vyvanse20MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Vyvanse40MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Vyvanse60MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Vyvanse10MG · capsule;oral | Lisdexamfetamine Dimesylate | RxReference drug |
| Apr 23, 2026 | Supplement 52Labeling · Standard review | Approved | |
| Sep 23, 2025 | Supplement 54Labeling · Standard review | Approved | |
| Oct 13, 2023 | Supplement 50Labeling · Standard review | Approved | |
| Feb 25, 2022 | Supplement 48Labeling | Approved | |
| Nov 2, 2021 | Supplement 47Labeling · Standard review | Approved | |
| Jul 29, 2021 | Supplement 46Efficacy (new indication or use) · Priority review | Approved | |
| Jul 31, 2017 | Supplement 34Labeling · Standard review | Approved | |
| May 19, 2017 | Supplement 45Labeling | Approved | |
| Jan 28, 2017 | Supplement 44Labeling · Standard review | Approved | |
| Jan 6, 2017 | Supplement 43Labeling | Approved | |
| Oct 14, 2016 | Supplement 42Labeling · Standard review | Approved | |
| Oct 14, 2016 | Supplement 41Efficacy (new indication or use) · Standard review | Approved | |
| Apr 15, 2016 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2015 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Apr 17, 2015 | Supplement 39Labeling · Standard review | Approved | |
| Jan 30, 2015 | Supplement 37Efficacy (new indication or use) · Priority review | Approved | |
| Jan 30, 2015 | Supplement 36Labeling · Standard review | Approved | |
| Nov 14, 2014 | Supplement 33Labeling · Standard review | Approved | |
| Oct 30, 2014 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2014 | Supplement 32Labeling · Standard review | Approved | |
| Jul 18, 2014 | Supplement 31Labeling · Standard review | Approved | |
| May 14, 2014 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Dec 6, 2013 | Supplement 30Labeling · Standard review | Approved | |
| Jun 14, 2013 | Supplement 28Labeling · Standard review | Approved | |
| Apr 26, 2013 | Supplement 27Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 2012 | Supplement 24Labeling · Standard review | Approved | |
| Nov 19, 2012 | Supplement 25Labeling · Standard review | Approved | |
| Nov 19, 2012 | Supplement 26Labeling · Standard review | Approved | |
| Jan 31, 2012 | Supplement 22Efficacy (new indication or use) · Standard review | Approved | |
| Sep 1, 2011 | Supplement 23Labeling · Standard review | Approved | |
| Mar 16, 2011 | Supplement 12Labeling | Approved | |
| Nov 10, 2010 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Nov 10, 2010 | Supplement 18Labeling | Approved | |
| Nov 10, 2010 | Supplement 19Labeling | Approved | |
| Nov 10, 2010 | Supplement 21Labeling · Standard review | Approved | |
| Apr 5, 2010 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Apr 5, 2010 | Supplement 15Labeling | Approved | |
| Dec 2, 2009 | Supplement 13Labeling · Standard review | Approved | |
| May 22, 2009 | Supplement 6Labeling · Standard review | Approved | |
| May 22, 2009 | Supplement 7Efficacy (new indication or use) | Approved | |
| Nov 12, 2008 | Supplement 8Labeling · Standard review | Approved | |
| Apr 23, 2008 | Supplement 1Efficacy (new indication or use) | Approved | |
| Dec 10, 2007 | Supplement 2Manufacturing | Approved | |
| Feb 23, 2007 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
