Aurobindo Pharma receives USFDA approval for Eptifibatide Injection

10 Dec 2015 Evaluate

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Eptifibatide Injection USP, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL single-use vials. This product is expected to be launched in this month. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Integrilin Injection, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL of Schering Corporation.

Eptifibatide Injection is used in the treatment of acute coronary syndrome. The approved product has an estimated market size of $137 million for the twelve months ending October 2015 according to IMS.

The pharma major now has 18 ANDAs (including one tentative approval) approved out of Unit IV formulation facility in Hyderabad, India for manufacturing general injectable products. Aurobindo now has a total of 222 ANDA approvals (194 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.



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