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.
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The approved product has an estimated market size of US $ 123 million for the 12 months ending February 2015, according to IMS.
Amlodipine and Valsartan tablets are used in the treatment of hypertension, to lower blood pressure.