Adverse Drug Reaction

U.S. FDA approves i.v. immune globulin for adverse reactions to smallpox vaccine

Published in Medical Letter on the CDC and FDA, March 27th, 2005

Computer Sciences Corp. (CSC) announced that the U.S. Food and Drug Administration (FDA) has approved its Vaccinia Immune Globulin (VIGIV), an intravenous immune globulin, to treat rare adverse reactions to smallpox vaccination.

The VIGIV program is managed by DVC, LLC, a CSC company, for the U.S. Department of Defense joint vaccine acquisition program (JVAP) product management office.

VIGIV is the first FDA-licensed product for both DVC and the JVAP. The VIGIV program was granted fast track and orphan drug designation by the FDA. "Orphan" designation is a special status granted to a product that treats a rare disease or condition.

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Source: Medical Letter on the CDC and FDA (2005-03-27)

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