Aurobindo Pharma has received final approvals from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan and Hydrochlorothiazide Tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg (ANDA 202519). The product is ready for launch.
Valsartan and Hydrochlorothiazide Tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg is generic equivalent to Novartis Pharmaceuticals Corp.’s Diovan HCT Tablets 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg respectively. The product is indicated for the treatment of hypertension, to lower blood pressure and falls under the cardiovascular (CVS) therapeutic category. The market size of the product is approximately US$1.7 Billion for the twelve months ending September 2012.
Aurobindo now has a total of 181 ANDA approvals (156 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA.
