Aurobindo Pharma Ltd has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Bivalirudin injection. The approved ANDA is a generic equivalent to the reference listed drug (RLD) product Angiomax Injection of The Medicines Company.
Bivalirudin injection is indicated for use as an anti-coagulant in some patients. The estimated market size of the Bivalirudin injection is $101 million for the 12 months ending May 2018, according to IQVIA. The product will be launched in September 2018.
Aurobindo now has a total of 381 ANDA approvals (348 final approvals, including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.