Alembic Pharma gets USFDA approval for generic heart failure medication

13 Nov 2024 , 09:20 AM

The United States Food and Drug Administration (USFDA) granted final approval on Tuesday to Alembic Pharmaceuticals Ltd for Ivabradine tablets, a medication for lowering hospitalisations due to heart failure.

Alembic Pharma’s Abbreviated New Drug Application (ANDA) for Ivabradine tablets in doses of 5 mg and 7.5 mg has received final approval from the US Food and Drug Administration.

The authorised ANDA is a therapeutic equivalent of the reference-listed drug (RLD), Corlanor tablets, in the same 5 mg and 7.5 mg dosages, produced by Amgen Inc., an American biopharmaceutical company.

Ivabradine inhibits cyclic nucleotide-gated channels that are triggered by hyperpolarisation. Alembic Pharma announced in a press release that it is intended for lowering the risk of hospitalisation in adult patients with stable, symptomatic chronic heart failure and decreasing left ventricular ejection fractions.

According to IQVIA MAT statistics for the 12-month period ending September 2024, Ivabradine tablets, 5 mg and 7.5 mg, have an anticipated market size of USD 145.3 million in the United States.

The Vadodara-based pharmaceutical business currently has a total of 218 ANDA approvals from the USFDA, including 192 final and 26 tentative clearances.

Diltiazem Hydrochloride Extended-Release capsules are used to treat hypertension and can be taken alone or with other antihypertensive drugs. They’re also used to treat chronic stable angina and angina caused by coronary artery spasms.

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