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Posted 30 Apr 2015 by Drugs.com
April 30, 2015 – The U.S. Food and Drug Administration today approved Raplixa (fibrin sealant [human]), the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery. Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding. Raplixa contains fibrinogen and thrombin, two proteins found in human plasma, the liquid portion of blood. The two protein components are individually purified using a manufacturing process that includes virus inactivation and removal steps to help reduce the ... Read more