Alembic receives USFDA approval for Olmesartan Medoxomil Tablets and Olmesartan Medoxomil
Alembic Pharmaceuticals Limited 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.
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The approved ANDAs are therapeutically equivalent to the reference listed drug products (RLDs) Benicar Tablets 5mg, 20mg and 40mg and Benicar HOT® 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 HOT have an estimated market size of US$ 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.