Mumbai, July 20, 2017: Pharma Major, Alembic Pharmaceuticals Limited today said that the company has received approval from the 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 Azor tablets of Daiichi Sankyo Inc., company said in filing with BSE.
Olmesartan Medoxomil and Amlodipine tablets are indicated for the treatment of hypertension, alone or with antihypertensive agents to lower blood pressure.
Olmesartan Medoxomil and Amlodipine tablets have an estimated market size of USD 312 million for twelve months ending December 2016, according to IMS.
Alembic now has a total of 61 ANDA approvals (53 final approvals and 8 tentative approvals) from USFDA.
United News of India
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