Valsartan tablet is an angiotensin II receptor blocker (ARB) indicated for: Hypertension, to lower blood pressure in adults and children 6 years and older. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions Heart failure (NYHA class II to 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 5, 2015 | Original application | Approved | None posted |
| Sep 3, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 3, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 20, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 5, 2015 | Original application | Approved | None posted |
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
