Alembic Pharma secures USFDA nod for generic heart failure medication

Alembic Pharmaceuticals Ltd received final approval on Tuesday from the United States Food and Drug Administration (USFDA) for Ivabradine tablets, a treatment for reducing hospitalisations due to heart failure.

The US health regulator granted final approval for Alembic Pharma's Abbreviated New Drug Application (ANDA) for Ivabradine tablets in 5 mg and 7.5 mg doses.

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

Ivabradine is a hyperpolarisation-activated cyclic nucleotide-gated channel blocker. It is indicated for reducing hospitalisation risk in adult patients with stable, symptomatic chronic heart failure and reduced left ventricular ejection fraction, Alembic Pharma stated in a press release.

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Shares of Alembic Pharma opened higher at ₹1,035.5 on the BSE, rising over 1.3% to an intraday high of ₹1,044.70.

According to IQVIA MAT data for the twelve months ending September 2024, Ivabradine tablets, 5 mg and 7.5 mg, hold an estimated market size of USD 145.3 million in the United States.

The Vadodara-based pharmaceutical company has now received a cumulative total of 218 ANDA approvals from the USFDA, including 192 final and 26 tentative approvals.

Alembic Pharma also received final USFDA approval for Diltiazem Hydrochloride Extended-Release capsules, used in treating hypertension.

Diltiazem Hydrochloride Extended-Release capsules are indicated for managing hypertension and can be used alone or alongside other antihypertensive medications. They are also prescribed for treating chronic stable angina and angina resulting from coronary artery spasms.

Shares of Alembic Pharmaceuticals Ltd closed up 0.26% at ₹1,033.70 on the BSE.