Smallpox

FDA accepts BLA filing for Vaccinia Immune Globulin

Published in Vaccine Weekly, September 1st, 2004

Computer Sciences Corp. (CSC) announced the U.S. Food and Drug Administration (FDA) has accepted DynPort Vaccine Co.'s (DVC) filing of a biologics license application for Vaccinia Immune Globulin (VIGIV), an intravenous immune globulin under evaluation for the treatment of adverse reactions to smallpox vaccination.

DVC is a CSC company.

The application was submitted on May 21, 2004 and accepted for review on July 15, 2004. Acceptance for filing indicates recognition by the FDA that the submission is complete and warrants full review of the data needed to assess the quality, safety, and efficacy of the therapeutic.

Cato Research,...

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Source: Vaccine Weekly (2004-09-01)

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