Baxter International, Inc. (BAX) Files For Pediatric Indication Of RIXUBIS [Coagulation Factor IX (Recombinant)] Treatment For Hemophilia B In The United States
12/9/2013 9:59:14 AM
DEERFIELD, Ill.--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX) today announced that it has submitted an application to the United States Food and Drug Administration (FDA) for a pediatric indication for RIXUBIS [Coagulation Factor IX (Recombinant)] to treat hemophilia B. The submission was based on the results of a study presented during the 55th Annual Meeting of the American Society of Hematology (ASH) in New Orleans, LA. RIXUBIS was approved in the United States for adults with hemophilia B earlier this year and the company filed for marketing approval in Europe in November.
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