Alembic Pharma Gets USFDA Nod To Market Heart Failure Drug
The company has received final approval from the US Food & Drug Administration (USFDA) for Sacubitril and Valsartan Tablets in strengths of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Alembic said in a regulatory filing.
Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic medication used to treat certain types of heart failure.
The company has received final approval from the US Food & Drug Administration (USFDA) for Sacubitril and Valsartan Tablets in strengths of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Alembic said in a regulatory filing.
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The approved product is therapeutically equivalent to Novartis's Entresto tablets.
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.
According to IQVIA, Sacubitril and Valsartan tablets have an estimated market size of USD 5.3 billion for twelve months ending March 2024.
Shares of Alembic Pharma on Thursday ended 0.34 per cent down at Rs 942.95 apiece on the BSE.
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