Alembic Pharmaceuticals today announced that the Company has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) for Olmesartan Medoxomil Tablets, 5 mg, 20mg and 40mg and Olmesartan Medoxomil with Hydrochlorothiazide Tablets 20/12.5mg, 40/12.5mg and 40/25mg.
The approved ANDAs are therapeutically equivalent to the reference listed drug products (RLDs) Benicar Tablets 5mg, 20mg and 40mg and Benicar HCT Tablets, 20/12.5mg, 40/12.5mg and 40/25mg, of Daiichi Sankyo Inc. Approved ANDAs are indicated for the treatment of hypertension.
Benicar and Benicar HCT have an estimated market size of USD 1.8 billion for twelve months ending December 2016 according to IMS.
Alembic now has a total of 55 ANDA approvals (49 final approvals and 6 tentative approvals) from the USFDA.
Shares of the company gained Rs 17.6, or 2.9%, to trade at Rs 625.00. The total volume of shares traded was 5,261 at the BSE (10.30 a.m., Tuesday).