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Baxter International Inc files for pediatric indication of RIXUBIS


Monday, 9 Dec 2013 09:00am EST 

Baxter International Inc:Says it has submitted an application to the United States Food and Drug Administration (FDA) for 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.Says 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.Says 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 Nov. a pediatric indication for RIXUBIS [Coagulation Factor IX (Recombinant)] to treat hemophilia B. 

Company Quote

72.81
-0.64 -0.87%
17 Apr 2014