Aurobindo Pharma Ltd. said it had received final approvals from the US FDA to manufacture and market Valsartan and Hydrochlorothiazide tablets USP, 80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg and 320mg/25mg covered under ANDA 202519.
The company said the product was 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.
As per IMS data, the market size of the product is around $1.7 billion for the twelve months ended September 2012.
The company now has a total of 181 ANDA approvals (156 final approvals including 2 from Aurolife Pharma LLC and 25 tentative approvals) from the US FDA.
At the BSE, Aurobindo Pharma shares are currently trading at Rs.138.40, down 4.95 percent from the previous close.
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