Alembic Pharma gets USFDA tentative nod for lvabradine Tablets

20 Apr 2022 , 03:45 PM

Alembic Pharmaceuticals Limited on Wednesday announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for lvabradine Tablets, 5 mg and 7.5 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). lvabradine Tablets are indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction <=35%, 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.

lvabradine Tablets are indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 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.

Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 102 million for twelve months ending December 2021 accordinq to IQVIA.

Alembic has received a cumulative total of 164 ANDA approvals (140 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals ended at Rs757.70 apiece up by Rs8.9 or 1.19% on the BSE.