FDA approves Hospira’s Angiomax generic

LAKE FOREST, Ill. — Injectable and infusion drug company Hospira announced Thursday that the Food and Drug Administration had approved its bivalirudin injection, a generic of the Medicine Company’s Angiomax.

The injection is available in single-dose flip-top vial for use by patients with unstable angina undergoing perutanious transluminal coronary angioplasty, percutaneous coronary intervention and those with heparin-induced thrombocytopenia and thrombosis syndrome. 

“Hospira is excited to launch the first generic of bivalirudin based on a successful challenge of the originator's patents,” Hospira’s President of U.S. Commercial Philippe Drouet said. “This approval further demonstrates our commitment to bringing safe, lower-cost generic versions of important medications to the market as soon as possible.”

Bivalirudin, which is intended to be used with aspirin, joins Hospira’s line of some 200 injectable generics.