23rd May, 2025, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Amlodipine and Atorvastatin Tablets USP, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Caduet Tablets, 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of Pharmacia and Upjohn Co. LLC.
Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Refer label for a detailed indication.
Alembic has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from USFDA.
