Aurobindo receives USFDA approval for hypertension drug

Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan tablets.


Valsartan tablets USP, 40mg, 80mg, 160mg and 320mg are the generic equivalent to the reference listed drug product (RLD) Diovan tablets, 40 mg, 80 mg, 160 mg and 320 mg respectively of Novartis and indicated for the treatment of hypertension, to lower blood pressure.

The product falls under the therapeutic category of CVS (Cardio Vascular) and has a market size of approximately $2 billion for the twelve months ending October 2014 according to IMS.

Aurobindo now has a total of 195 ANDA approvals (170 final approvals including 7 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA.

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