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Aurobindo gets final USFDA nod for launch of hypertension drug

Valsartan tablets are the generic equivalent to the reference listed drug product, Diovan tablets, of Novartis Pharmaceuticals Corporation

Aurobindo Pharma
BS Reporter Hyderabad
Last Updated : Jan 06 2015 | 5:55 PM IST
Hyderabad-based Aurobindo Pharma Limited announced today that the company had received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Valsartan tablets.

The product, which is used to treat high blood pressure among other ailments, is ready for launch, Aurobindo said.

Valsartan tablets are the generic equivalent to the reference listed drug product (RLD) Diovan tablets of Novartis Pharmaceuticals Corporation.

The products fall under the therapeutic category of CVS (Cardio Vascular) has a market size of approximately $ 2 billion for the twelve months ending October, 2014, the release said citing the IMS data.

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

Lupin announces the launch of Valsartan in the US

Meanwhile, pharma major Lupin Limited announced today that its US subsidiary, Lupin Pharmaceuticals Inc. has launched its Valsartan tablets, after having received final approval from the US drug regulator.

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First Published: Jan 06 2015 | 5:46 PM IST

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