Aurobindo Pharma receives USFDA Approval for Amlodipine and Valsartan Tablets.

The USFDA has approved manufacture and marketing of Amlodipine and Valsartan tablets USP, in dosages of 5mg/160mg, 10mg/160mg, 5mg/320mg and 10 mg/320mg. The product is expected to be launched in Q1 FY16-17, the company said in a release.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exforge tablets of Novartis Pharmaceuticals Corporation, the release added.

The approved product has an estimated market size of US $ 123 million for the 12 months ending February 2015, according to IMS.

Press Release