LAKE ZURICH, Ill. November 7, 2016 – Fresenius Kabi announced today it has introduced Bivalirudin for Injection in the United States. Bivalirudin for Injection, an anticoagulant, is a generic alternative to Angiomax®. Fresenius Kabi Bivalirudin was approved by the U.S. Food and Drug Administration in October. According to IMS the U.S. market for Bivalirudin for Injection is approximately $240 million.
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
Fresenius Kabi Bivalirudin for Injection is available in single-dose vials, each containing 250 mg of Bivalirudin. The drug was developed and is manufactured in the United States.
“We are pleased to offer a generic alternative to Angiomax,” said John Ducker, president and CEO of Fresenius Kabi USA. “This addition to our portfolio of critical care medicines is the most recent example of the commitment Fresenius Kabi makes to putting essential medicines in the hands of people who care for patients.”
Bivalirudin for Injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients:
- with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
- 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. Bivalirudin for Injection is intended for use with aspirin.
Limitation of use: Safety and effectiveness not established in patients with acute coronary syndromes who are not undergoing PTCA or PCI.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion, and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany.
Angiomax® (Bivalirudin for injection) is a registered trademark of The Medicines Company.