Posted by Michael Wonder on 13 Dec 2016
Emergent BioSolutions receives Health Canada approval for botulism anti-toxin
12 December 2016 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its botulism antitoxin, BAT [Botulism Anti-toxin Heptavalent (A, B, C, D, E, F, G) - (equine)]
BAT is indicated for the treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and paediatric patients.
BAT was approved under the extra-ordinary use new drug regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.
