Baxter International has received the FDA's approval to market Rixubis, or coagulation factor IX (recombinant), for the treatment of children with hemophilia B. The drug was approved for use in routine prophylaxis, perioperative management and control of bleeding episodes.
Baxter International's Rixubis recombinant factor IX has been approved by the FDA for routine prophylactic treatment, perioperative management and the control and prevention of bleeding episodes in children with hemophilia B. The approval was based on a study involving 23 children younger than 12.
Baxter has asked the FDA to expand the indications of the hemophilia B drug Rixubis to include the treatment of children. A Phase II/III trial evaluated the use of Rixubis in boys younger than 12 years of age with severe or moderately severe hemophilia B.
People who perceived stress as a significant factor affecting their health had a twofold increased risk of suffering coronary heart disease compared with those who did not, a study in the European Heart Journal indicated.
Baxter International said it will stop running some of the ads for its Advate hemophilia treatment because the FDA is questioning its description of the drug's side effects and the way Baxter backs up claims contained in promotional literature going to physicians. Baxter said it will submit a written response to the federal health agency that lays out a plan to resolve the issues.