NEW DELHI: Aurobindo Pharma has received US health regulator’s approval to market Eptifibatide Injection, used in the treatment of acute coronary syndrome, in the American market.
The company has received final approval from the US Food and Drug Administration (USFDA) 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 USD 137 million for the 12 months ending October 2015.
Aurobindo now has 18 abbreviated new drug application 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 USFDA.