Vaccine Weekly
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Vaccine Weekly
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Emergent BioSolutions Inc.
Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application
January 7th, 2009
Emergent BioSolutions Inc. (NYSE:EBS) announced that the U.S. Food and Drug Administration (FDA) has approved Emergent’s supplemental Biologics License Application (sBLA) for Anthrax Vaccine Adsorbed (BioThrax®), the only FDA-licensed vaccine to prevent disease caused by Bacillus anthracis. The supplement provides for a change in the route of administration and a reduction in the total number of vaccinations. The new schedule for BioThrax is five intramuscular (IM) doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous (SC) doses at 0, 2 weeks and 1, 6, 12, 18 months. The sBLA was based on results from a planned interim analysis of...
Source: Vaccine Weekly (2009-01-07)
|
