Alembic Pharma gets USFDA nod for Sacubitril and Valsartan Tablets for heart failure
Vadodara: Alembic Pharmaceuticals Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Entresto Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, of Novartis Pharmaceuticals Corporation.
Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older.
Sacubitril and Valsartan Tablets have an estimated market size of US$ 5.3 billion for twelve months ending March 2024 according to IQVIA. Alembic has a cumulative total of 202 ANDA approvals (174 final approvals and 28 tentative approvals) from USFDA.
Read also: Alembic Pharma gets tentative USFDA nod for breast cancer drug Ribociclib in March Quarter
Medical Dialogues team had earlier reported that the company had received tentative approval from the USFDA for its ANDA for lvabradine Tablets, 5 mg and 7.5 mg. 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.
Read also: Alembic Pharma gets USFDA nod for heart failure drug lvabradine
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.
Read also: USFDA approves Alembic Pharma five products in over a month
