Lowers the risk of cardiovascular death and hospitalization for heart failure. NDA 218591, held by Novartis. Sacubitril; Valsartan.
As of Nov 13, 2026, NDA 218591 (Entresto Sprinkle), held by Novartis, was first approved by FDA on Apr 12, 2024, with 0 approved supplements and 0 published complete response letters.
ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 12, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Entresto Sprinkle6MG;6MG · capsule, pellets;oral | Sacubitril; Valsartan | RxReference drug |
| Entresto Sprinkle15MG;16MG · capsule, pellets;oral | Sacubitril; Valsartan | RxReference drug |
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
