FDA approves Baxter's hemophilia B product

FDA approved a BLA for Rixubis ( BAX 326) from Baxter International Inc. (NYSE:BAX) to treat hemophilia B in patients 16 years of age or older. The recombinant Factor IX (rFIX) protein is approved to control and prevent bleeding episodes, perioperative management and for routine prophylactic use to prevent or reduce bleeding episodes. FDA said Rixubis is the first rFIX to be indicated specifically for prophylaxis. Baxter plans to launch the product in the U.S. in 4Q13. The company said it plans to submit a regulatory application in the EU before year end. ...