The medicine is a direct thrombin inhibitor designed as an anticoagulant. Mylan’s bivalirudin single-dose vial was approved by the FDA for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty.
The product is also indicated for those undergoing percutaneous coronary intervention with provisional use of GPI or for those undergoing PCI with heparin-induced thrombocytopenia or heparin-induced thrombocytopenia and thrombosis syndrome.
Mylan noted that its Angiomax generic is intended for use in the aforementioned indications alongside aspirin.
Injectable bivalirudin brought in $106 million in U.S. sales for the year ended March 31, according to IQVIA.
Also this month, the FDA approved the first generic version of Indivior‘s (LON:INDV) billion-dollar opioid addiction treatment, Suboxone. The generic buprenorphine and naloxone sublingual film, sold by Dr. Reddy’s Laboratories (NYSE:RDY) and Mylan, is designed to suppress withdrawal symptoms that crop in people addicted to opioids, as well as block the neurochemical effects of opioids.
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