New Delhi: Drug firm Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator for generic Olmesartan Medoxomil and Amlodipine tablets used for the treatment of hypertension.
The company has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olmesartan Medoxomil and Amlodipine tablets, Alembic Pharmaceuticals said in a BSE filing.
The approval is for the tablets in the strengths of 20mg/5mg, 40 mg/5 mg, 20 mg/10 mg and 40 mg/10 mg, it added.
The product is generic version of Daiichi Sankyo Inc’s Azor tablets in the same strengths, Alembic Pharma said.
The tablets are indicated for the treatment of hypertension, alone or with antihypertensive agents to lower blood pressure, it added.
According to IMS the Olmesartan Medoxomil and Amlodipine tablets had an estimated market size of USD 312 million for twelve months ending December 2016.
The company has a total of 61 ANDA approvals from the USFDA.