The Vadodara-based Alembic Pharmaceuticals has received final approval from US Food and Drug Administration (FDA) for its abbreviated new drug applications (ANDAs) for olmesartan medoxomil tablet (5 mg, 20 mg & 40 mg) and olmesartan medoxomil with hydrochlorothiazide tablet (20/12.5 mg, 40/12.5 mg and 40/25 mg).
The approved drugs are generic versions of Daiichi Sankyo's Benicar and Benicar tablets, which are indicated for the treatment of hypertension.
Benicar and Benicar HCT have an estimated market size of $ 1.8 billion for twelve months ending December 2016, according to IMS.
Alembic now has a total of 55 ANDA approvals (49 final approval and 6 tentative approvals) from the US FDA.
