Alembic Pharmaceuticals receives USFDA Final Approval for Sacubitril and Valsartan Tablets

Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Entresto Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, of Novartis Pharmaceuticals Corporation (Novartis).

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalisation for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.

Sacubitril and Valsartan Tablets have an estimated market size of US$ 5.3 billion for twelve months ending March 2024 according to IQVIA.

Alembic has a cumulative total of 202 ANDA approvals (174 final approvals and 28 tentative approvals) from USFDA.