Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg. The product is ready for launch.
Valsartan Tablets USP, 40mg, 80mg, 160mg and 320mg are the generic equivalent to the reference listed drug product (RLD) Diovan Tablets, 40mg, 80mg, 160mg and 320mg respectively of Novartis Pharmaceuticals Corporation (Novartis) and indicated for the treatment of hypertension, to lower blood pressure. The product falls under the therapeutic category of CVS (Cardio Vascular) has a market size of approximately USD 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.
Shares of the company declined Rs 41.7, or 3.69%, to settle at Rs 1,088.30. The total volume of shares traded was 37,367 at the BSE (Tuesday).