Aurobindo Pharma has received final USFDA approval to manufacture and market Bivalirudin injection, 250 mg/vial. The drug Bivalirudin is a generic equivalent to the reference listed drug (RLD) product Angiomax Injection of The Medicines Company. The estimated market for the drug Bivalirudin injection is US$ 101 million for the twelve months ending May 2018. The company is likely to launch the drug in September 2018.
The Bivalirudin injection is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty or undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study
Company Profile : Aurobindo Pharma Ltd