Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (FDA) to manufacture and market amlodipine and valsartan tablets - 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg and 10 mg/320 mg. This product, which is a generic version of Norvartis’ Exforge tablets, is expected to be launched in Q1 FY16-17.
Amlodipine and valsartan tablets are used in the treatment of hypertension, to lower blood pressure. The approved product has an estimated market size of $ 123 million for the twelve months ending February 2016, according to IMS.