Aurobindo gets USFDA nod for Hydrochlorothiazide tablets

HYDERABAD: Drugmaker Aurobindo Pharma Limited today said the company has received final approvals from the US Food and Drug Administration (USFDA) to manufacture and market Valsartan and Hydrochlorothiazide Tablets USP.

This would be in quantities of 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg.

In a statement, Aurobindo said the drug, a generic equivalent to Novartis Pharmaceuticals Corp's Diovan HCT Tablets, is ready for launch.

The product is indicated for the treatment of hypertension, to lower blood pressure and falls under the cardiovascular (CVS) therapeutic category, Aurobindo said.

The market size of the product is approximately $1.7 billion for twelve months ending September 2012, according to IMS Health.

Aurobindo now has a total of 181 ANDA approvals (156 Final approvals including 2 from Aurolife Pharma LLC and 25 Tentative approvals) from USFDA, the statement said.

Aurobindo shares are quoted at Rs 139.75 apiece down 4.02 per cent during afternoon trade on Bombay Stock Exchnage.