Trade Resources Industry Views Emergent Biosolutions Has Obtianed FDA Approval to Changing The Administration Schedule

Emergent Biosolutions Has Obtianed FDA Approval to Changing The Administration Schedule

Emergent BioSolutions has received FDA approval for its supplemental Biologics License Application (sBLA) to change the administration schedule of BioThrax to a three-dose primary series of intramuscular injections at zero, one, and six months.

BioThrax (Anthrax Vaccine Adsorbed) is the vaccine for pre-exposure protection of adults against anthrax disease.

The booster series consists of intramuscular injections at 12 and 18 months after initiation of the primary series, and at one-year intervals thereafter for those who remain at risk.

Until the individuals have completed the three-dose primary immunization series, they are not considered protected.

Emergent president and chief executive officer Daniel Abdun-Nabi said, "Emergent applauds the Centers for Disease Control and Prevention (CDC) for their dedicated research to optimize the dosing schedule of BioThrax and the FDA for a timely review and approval process."

 

Source: http://drugdelivery.pharmaceutical-business-review.com/news/emergent-wins-fda-approval-for-change-in-biothrax-administration-schedule-180512
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Emergent Wins FDA Approval for Change in Biothrax Administration Schedule