Diovan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 1 year and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II-IV), to reduce hospitalization for heart failure in adults Post-myocardial infarction, for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction in adults 1.
| Apr 19, 2021 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Nov 29, 2007 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Aug 3, 2005 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Apr 5, 2002 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2001 | Original applicationNew dosage form · Standard review | Approved |
| Jul 21, 2025 | Supplement 62Manufacturing | Approved | |
| Jul 22, 2021 | Supplement 59Manufacturing | Approved | |
| Apr 19, 2021 | Supplement 58Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2019 | Supplement 53Labeling · Standard review | Approved | |
| Feb 3, 2017 | Supplement 50Labeling · Standard review | Approved | |
| Jul 31, 2015 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Jul 27, 2015 | Supplement 46Labeling · Standard review | Approved | |
| Sep 26, 2014 | Supplement 44Labeling · Standard review | Approved | |
| Mar 17, 2014 | Supplement 42Labeling · Standard review | Approved | |
| Mar 17, 2014 | Supplement 41Labeling · Standard review | Approved | |
| Oct 18, 2013 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Oct 4, 2012 | Supplement 39Labeling | Approved | |
| Jul 26, 2012 | Supplement 37Labeling | Approved | |
| Feb 28, 2012 | Supplement 35Labeling | Approved | |
| Jan 18, 2012 | Supplement 36Labeling | Approved | |
| Dec 12, 2011 | Supplement 33Labeling | Approved | |
| Jun 3, 2011 | Supplement 32Labeling | Approved | |
| Jun 15, 2009 | Supplement 27Labeling · Standard review | Approved | |
| Nov 29, 2007 | Supplement 24Efficacy (new indication or use) · Priority review | Approved | |
| Aug 17, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Nov 22, 2006 | Supplement 18Labeling · Standard review | Approved | |
| Aug 3, 2005 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Nov 30, 2004 | Supplement 12Labeling · Standard review | Approved | |
| Nov 6, 2002 | Supplement 4Manufacturing · Standard review | Approved | |
| Sep 13, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 14, 2002 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Aug 1, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Apr 29, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 5, 2002 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 18, 2001 | Original applicationNew dosage form · 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
