Alembic Pharmaceuticals Limited (Alembic) recently informed exchanges that the US Food and Drug Administration (USFDA) has granted Final Approval for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg.
This approval grants Alembic the go-ahead to offer a therapeutically equivalent product to Corlanor Tablets, developed by Amgen Inc., for the U.S. market. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker used to reduce hospitalization risk in adults with chronic heart failure and reduced left ventricular ejection fraction.
The approved Ivabradine Tablets have an estimated market size of $145.3 million (IQVIA, twelve months ending September 2024), positioning Alembic to serve a substantial market segment in the U.S. With this latest addition, Alembic now has a cumulative total of 218 ANDA approvals (192 final and 26 tentative) from the USFDA.
