Lupin Receives U.S. FDA Approval for Sacubitril and Valsartan Tablets

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated new Drug Application (ANDA), Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, the generic version of Entresto Tablets, 24mg/26mg, 49 mg/51mg, and 97 mg/103 mg.

Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, the generic version of Entresto Tablets, 24mg/26mg, 49 mg/51mg, and 97 mg/103 mg of Novartis Pharmaceuticals Corporation, are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and reduced ejection fraction and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older.

Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, had estimated annual sales of USD 6,061 million in the U.S. (IQVIA MAT November 2024).