Mumbai: Pharma Major Aurobindo Pharma said that it has received final approval from the US Food and 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 company said in a filing with the BSE.
The estimated market size of Bivalirudin injection is USD 101 million for 12 months ended May, 2018, according to IQVIA. The product will be launched in September 2018.
Bivalirudin injection is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
It is also used for patients undergoing percutaneous coronary intervention (PCI), with provisional use of glycoprotein IIb/IIIa inhibitor (GPI), as in the REPLACE-2 study.
And also used for patients with, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI.
Bivalirudin is intended for use in these indications with aspirin.
This is the 53rd ANDA (including one tentative approval), to be approved out of Unit IV formulation facility in Hyderabad, India, used for manufacturing general injectable & ophthalmic products.
Aurobindo now has a total of 381 ANDA approvals (348 Final approvals, including 17 from Aurolife Pharma LLC and 33 tentative approvals) from USFDA.
UNI JS NV RJ 1242