Lowers the risk of total mortality. NDA 21687, held by Organon. Ezetimibe; Simvastatin.
As of Nov 14, 2026, NDA 21687 (Vytorin), held by Organon, was first approved by FDA on Jul 23, 2004, with 43 approved supplements and 0 published complete response letters.
VYTORIN VYTORIN is a combination of simvastatin and ezetimibe indicated: As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): In adults with primary hyperlipidemia. In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).
| Jan 24, 2012 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Jun 13, 2008 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | None posted |
| Oct 3, 2006 | Supplement 11Efficacy (new indication or use) | Approved | |
| Mar 16, 2006 | Supplement 6Efficacy (new indication or use) | Approved | |
| Jul 23, 2004 | Original applicationNew combination · Standard review | Approved |
| Vytorin10MG;10MG · tablet;oral | Ezetimibe; Simvastatin | RxReference drug |
| Vytorin10MG;20MG · tablet;oral | Ezetimibe; Simvastatin | RxReference drug |
| Vytorin10MG;40MG · tablet;oral | Ezetimibe; Simvastatin | RxReference drug |
| Vytorin10MG;80MG · tablet;oral | Ezetimibe; Simvastatin | RxReference drug |
| Mar 28, 2024 | Supplement 66Labeling · Standard review | Approved | |
| Feb 8, 2024 | Supplement 65Labeling · Standard review | Approved | |
| Feb 8, 2024 | Supplement 64Labeling · Standard review | Approved | |
| Feb 8, 2024 | Supplement 61Labeling · Standard review | Approved | |
| Sep 25, 2020 | Supplement 63Labeling | Approved | |
| Oct 4, 2019 | Supplement 62Labeling · Standard review | Approved | |
| Apr 2, 2019 | Supplement 52Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 60Labeling · Standard review | Approved | |
| Jan 19, 2017 | Supplement 57Manufacturing · Standard review | Approved | |
| Feb 2, 2015 | Supplement 53Labeling · Standard review | Approved | |
| Sep 30, 2014 | Supplement 51Labeling | Approved | |
| Feb 27, 2014 | Supplement 50Labeling · Standard review | Approved | |
| Oct 25, 2013 | Supplement 48Labeling · Standard review | Approved | |
| Oct 31, 2012 | Supplement 47Labeling | Approved | |
| Oct 31, 2012 | Supplement 46Labeling · Standard review | Approved | |
| Feb 28, 2012 | Supplement 44Labeling | Approved | |
| Jan 24, 2012 | Supplement 39Efficacy (new indication or use) · Standard review | Approved | |
| Dec 1, 2011 | Supplement 42Labeling | Approved | |
| Oct 6, 2011 | Supplement 41Labeling | Approved | |
| Jun 8, 2011 | Supplement 40Labeling | Approved | |
| Jun 8, 2011 | Supplement 33Labeling | Approved | |
| Dec 22, 2010 | Supplement 37Labeling | Approved | |
| Apr 22, 2010 | Supplement 36Labeling | Approved | |
| Mar 10, 2010 | Supplement 34Labeling | Approved | |
| Nov 6, 2009 | Supplement 32Labeling · Standard review | Approved | |
| Jan 30, 2009 | Supplement 30Labeling · Standard review | Approved | |
| Jan 8, 2009 | Supplement 29Labeling · Standard review | Approved | |
| Jun 13, 2008 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 13, 2008 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | None posted |
| Feb 8, 2008 | Supplement 22Labeling · Standard review | Approved | |
| Dec 12, 2007 | Supplement 21Labeling · Standard review | Approved | |
| May 16, 2007 | Supplement 19Labeling · Standard review | Approved | |
| Nov 27, 2006 | Supplement 16Manufacturing | Approved | |
| Oct 24, 2006 | Supplement 10Labeling · Standard review | Approved | |
| Oct 3, 2006 | Supplement 11Efficacy (new indication or use) | Approved | |
| Jul 3, 2006 | Supplement 15Labeling · Standard review | Approved | |
| Mar 16, 2006 | Supplement 13Labeling · Standard review | Approved | |
| Mar 16, 2006 | Supplement 6Efficacy (new indication or use) | Approved | |
| Dec 9, 2005 | Supplement 9Manufacturing · Standard review | Approved | |
| Oct 19, 2005 | Supplement 4Labeling · Standard review | Approved | |
| Jun 3, 2005 | Supplement 3Labeling · Standard review | Approved | |
| Mar 7, 2005 | Supplement 2Labeling · Standard review | Approved | |
| Feb 16, 2005 | Supplement 1Manufacturing · Standard review | Approved | |
| Jul 23, 2004 | Original applicationNew combination · 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
