Alembic Pharma receives US FDA tentative approval for Ivabradine tablets

Alembic Pharma today announced that it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ivabradine tablets, 5 mg and 7.5 mg. The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Corlanor tablets, 5 mg and 7.5 mg, of Amgen, Alembic Pharma notified in a statement.

Ivabradine tablets are indicated to reduce the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction ≤ 35 per cent, who are in sinus rhythm with resting heart rate ≥ 70 beats per minute and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Ivabradine tablets are indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged six months and older, who are in sinus rhythm with an elevated heart rate. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses, the statement added.