Aurobindo Pharma today said it has received final approval from the US health regulator to manufacture and market generic version of blood pressure treatment drugs Amlodipine and Valsartan tablets.
The approval by the US Food and Drug Administration (USFDA) is for multiple strengths of 5mg/160mg, 5mg/320mg and 10mg/320 mg, the company said in a BSE filing.
This product is expected to be launched in the first quarter of 2016-17, it added.
The drug is bio-equivalent and therapeutically equivalent to the reference listed product Exforge of Novartis Pharmaceuticals Corporation, it said.
Citing IMS data, the company said the approved product had an estimated market size of USD 123 million in the 12 month period ended February 2016.
This is the 71st ANDA to be approved out of Unit VII of the company’s formulation facility for oral non-antibiotic products in Hyderabad, Aurobindo Pharma said.
Shares of the company were trading 0.44 per cent up at Rs 768.60 apiece on the BSE.