Aurobindo Pharma receives USFDA Approval for Bivalirudin Injection

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bivalirudin injection, 250 mg/vial. The approved ANDA is a generic equivalent to the reference listed drug (RLD) product Angiomax® Injection of The Medicines Company. The estimated market size Bivalirudin injection is US$ 101 million for the twelve months ending May 2018 according to IQVIA. The product will be launched in September 2018.