Aurobindo Pharma receives USFDA Approval for Bivalirudin Injection

Aurobindo Pharma has received the final approval from the US Food and Drug Administration for Bivalirudin Injection indicated for the use as an anticoagulant in patients. The product will be launched in September 2018. With respect to the news, the shares of Aurobindo soared 2 per cent.

The company has been cleared 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 IOVIA.

The Bivalirudin Injection can treat anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty; undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study; with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI. The injection is intended for use in these indications with aspirin.

On Monday, the shares of Aurobindo opened at Rs. 592 per share and reached intraday high of Rs. 606.60 and intraday low of Rs. 587 per share on the BSE. The 52-week high was Rs. 808 and 52-week low was Rs. 527.05 per share on the BSE.

At 12:08 hours, the shares were trading at Rs. 603.05 per share up by 2 per cent on the BSE. The BSE Sensex was trading at 37,386.41 level, up by 0.13. Nifty50 traded at 11,288 level, up by 0.08 per cent on Monday