Vadodara: Alembic Pharmaceuticals Limited has announced that it has received Final Approval from
the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA)
Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the
reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. .
Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to
reduce the risk of hospitalization for worsening heart failure in adult patients with stable,
symptomatic chronic heart failure with reduced left ventricular ejection fraction. Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve
months ending September 2024 according to IQVIA.
Alembic has a cumulative total of 218 ANDA approvals (192 final approvals and 26 tentative
approvals) from USFDA.Read also: Alembic Pharma bags USFDA nod for hypertension drug Diltiazem Hydrochloride ERAlembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.Read also: Alembic Pharma gets USFDA nod to Diltiazem Hydrochloride ER Capsules to treat hypertension