Alembic Pharmaceuticals announced that it has received Final Approval from the US Food and 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.
Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalisation 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 $ 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.