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Alembic gets USFDA nod to market generic drugs

The company has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for lvabradine tablets (5 mg and 7.5 mg), Alembic Pharmaceuticals said in a regulatory filing.

PTI

April 20, 2022 / 12:17 PM IST

Alembic Pharmaceuticals on Wednesday said it has received approval from the US health regulator to market lvabradine tablets, used to treat heart failure, in the American market.

The company has received tentative approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for lvabradine tablets (5 mg and 7.5 mg), Alembic Pharmaceuticals said in a regulatory filing.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). lvabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure.

lvabradine Tablets are also indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate. According to IQVIA, lvabradine tablets (5 mg and 7.5 mg) have an estimated market size of USD 102 million for twelve months ending December 2021.

Alembic said it has now received a cumulative total of 164 ANDA approvals (140 final approvals and 24 tentative approvals) from the USFDA till date.

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