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Primary Immune Deficiency Diseases

U.S. Food and Drug Administration approves first immune globulin for subcutaneous use

Published in Medical Letter on the CDC and FDA, February 5th, 2006

The U.S. Food and Drug Administration (FDA) announced on January 9, 2006, the approval of the first immune globulin product for subcutaneous injection for the prevention of serious infections in patients with primary immune deficiency diseases (PIDD).

Vivaglobin, manufactured by ZLB Behring GmbH of Marburg, Germany, from human plasma collected at U.S. licensed plasma centers, provides new delivery options for PIDD patients. It is given under the skin (subcutaneously) on a weekly basis using an infusion pump, which means patients can self-administer the product at home. Some patients develop problems that make chronic intravenous administration of needed medicines...

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