Aurobindo Gets US Regulator's Nod to Market Heart Disease Drug

New Delhi: Aurobindo Pharma has received approval of the US Food and Drug Administration (FDA) to market injection Eptifibatide, used in the treatment of acute coronary syndrome, in the American market.

The company has received final approval from the US health regulator (FDA) to manufacture and market Eptifibatide Injection, Aurobindo Pharma said in a filing to the BSE.

This product is expected to be launched in this month, it added.

The Hyderabad-based firm's product is therapeutically equivalent to Schering Corporation's Integrilin injection.

Eptifibatide Injection is used in the treatment of acute coronary syndrome.

According to IMS data, the approved product had an estimated market size of $137 million for the 12-month ended October 2015.

Aurobindo now has 18 abbreviated new drug applications (ANDAs) approved out of Unit IV formulation facility in Hyderabad.

The company has a total of 222 ANDA approvals, including 10 from Aurolife Pharma LLC and 28 tentative approvals from FDA.      

Shares in Aurobindo Pharma, on Tuesday, ended 1.39 per cent lower at Rs 786.65 apiece on the BSE, whose benchmark Sensex index finished down 1.08 per cent.