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Alembic Pharmaceuticals Ltd’s shares were up by 0.92 per cent after the company reported that the US Food & Drug Administration granted final approval for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan tablets in various strengths.
This approval encompasses tablets containing 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg of the medication. The approved ANDA is deemed therapeutically equivalent to the reference listed drug product, Entresto tablets, manufactured by Novartis Pharmaceuticals Corporation.
Sacubitril and Valsartan tablets are prescribed for reducing the risk of cardiovascular death and hospitalisation for heart failure in adult patients with chronic heart failure. Additionally, they are indicated for treating symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.
The market size for Sacubitril and Valsartan tablets is estimated to be around $5.3 billion for the twelve months ending March 2024, according to IQVIA. The company has a total of 202 ANDA approvals from the USFDA, including 174 final approvals and 28 tentative approvals.
The shares were up by 0.92 per cent to ₹954 at 1.35 pm on the BSE.
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