Aurobindo Pharma 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 of Bivalirudin injection is US$ 101 million for the twelve months ended May 2018 according to IQVIA. The product will be launched in September 2018.
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