Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olmesartan Medoxomil and Amlodipine tablets. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Azor tablets of Daiichi Sankyo Inc.
The tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents to lower blood pressure. The tablets have an estimated market size of 2090 crorefor twelve months ending December 2016 according to IMS. Alembic now has a total of 61 ANDA approvals from USFDA.