Emergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThrax
Emergent BioSolutions Receives FDA approval for Supplemental Biologics License Application for BioThrax - Quick Facts
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Emergent BioSolutions Inc. (EBS: News ) announced that FDA has approved its supplemental Biologics License Application or sBLA for Anthrax Vaccine Adsorbed or BioThrax to prevent disease caused by Bacillus anthracis. The approval for supplement license was based on an interim analysis of data from a large multicenter study initiated in 2002.
The company said 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 doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous doses.
http://www.rttnews.com/Content/QuickFacts.aspx?Node=B1&Id=807804%20&Category=Quick%20Facts
Emergent BioSolutions Inc. (EBS: News ) announced that FDA has approved its supplemental Biologics License Application or sBLA for Anthrax Vaccine Adsorbed or BioThrax to prevent disease caused by Bacillus anthracis. The approval for supplement license was based on an interim analysis of data from a large multicenter study initiated in 2002.
The company said 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 doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous doses.
