sacubitril and valsartan
Drug Details
- Generic Name
- sacubitril and valsartan
- Brand Names
- sacubitril and valsartan
- Application Number
- ANDA213604
- Sponsor
- Torrent Pharmaceuticals Limited
- NDC Codes
- 21
- Dosage Forms
- TABLET, TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- SACUBITRIL, VALSARTAN
Indications and Usage
1 INDICATIONS AND USAGE Sacubitril and valsartan tablet 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. ( 1.1 ) • for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduce NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 ) 1.1 Adult Heart Failure Sacubitril and valsartan tablets are 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. LVEF is a variable measure, so use clinical judgment in deciding whom to treat [see Clinical Studies (14.1)]. 1.2 Pediatric Heart Failure Sacubitril and valsartan tablet is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. Sacubitril and valsartan tablet reduces NT-proBNP and is expected to improve cardiovascular outcomes.