Aurobindo Pharma Limited today said it got the approval of the US Food and Drug Administration (USFDA) to manufacture and market Bivalirudin injection of 250 mg/vial.
In a press release here, Aurobindo Pharma Ltd said the drug was a generic equivalent to the Angiomax injection.
The Bivalirudin injection was being used as an anti-coagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty among others, the release said.
The drug was intended for use with aspirin, it said.
Citing market reports, the release said the estimated market size of the Bivalirudin injection was USD 101 million for the year ending May 2018.
The product would be launched in September 2018, the release said.