Alembic Pharmaceuticals announced on Friday that it has received final approval from the US Food and Drug Administration (USFDA) for its generic version of amlodipine and atorvastatin tablets, used to manage high blood pressure.
The approval covers multiple dosage strengths—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—under the company's Abbreviated New Drug Application (ANDA).
These tablets are considered therapeutically equivalent to Caduet, the reference-listed drug manufactured by Pharmacia and Upjohn Co LLC, Alembic stated.