Alembic Pharma Gets USFDA Nod For Amlodipine-Atorvastatin Tablets

Alembic Pharmaceuticals on Friday said it has received final approval from the US Food and Drug Administration for its abbreviated new drug application for Amlodipine and Atorvastatin tablets.

The approval covers a wide range of strengths, the company said in an exchange filing.

Alembic said the approved product is therapeutically equivalent to Caduet tablets of Pharmacia and Upjohn Co. LLC. With this, the company’s total approvals from the USFDA now stand at 223, which includes 199 final and 24 tentative approvals.