Alembic Pharmaceuticals receives USFDA tentative approval for lvabradine Tablets

24 Apr 2022 , 01:34 AM

Alembic Pharmaceuticals today 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 75 mg The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product RLD Corlanor Tablets 5 mg and 75 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 <= 35Percentage 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 lvabradine Tablets 5 mg and 75 mg have an estimated market size of US$ 102 million for twelve months ending December 2021 according to IQVIA