Content about Center for Biologics Evaluation and Research

April 30, 2013
FDA approves anticoagulant-reversal product

The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug that reverses the effects of anticoagulant drugs in patients who have suffered acute major bleeding, the agency said.

The FDA announced the approval of CSL Behring's Kcentra (prothrombin complex concentrate [human]) for the urgent reversal of vitamin K antagonist, or VKA drugs such as warfarin.

January 17, 2013
FDA approves sterile blood-plasma product

The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

December 21, 2012
FDA approves biotech drug for reducing symptoms of severe chickenpox infection

The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for reducing the severity of chickenpox symptoms, the agency said Friday.

The FDA announced the approval of Cangene Corp.'s Varizig (varicella zoster immune globulin [human]) for varicella zoster, the virus that causes chickenpox. The FDA said Varizig was the only FDA-approved immune globulin for the virus after exposure.