Aurobindo Pharma Limited today has got the approval of the US Food and Drug Administration (USFDA) to manufacture and market Bivalirudin injection of 250 mg/vial.
The drug is a generic equivalent to the Angiomax injection, said Aurobindo Pharma in a press release.
The injection was being used as an anti-coagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty among others, said the release.
The drug was made for use with aspirin.
As per market reports, the estimated market size of the injection was $ 101 million for the year ended on May 2018.
The product is likely to be launched on September 2018, added the release.
The Pharma major now has a total of 381 ANDA (Abbreviated New Drug Application) approvals (348 final approvals, including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.