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Emergent BioSolutions secures Health Canada approval for botulism antitoxin

Emergent BioSolutions Inc. secured Health Canada's approval for its botulism antitoxin, Botulism Antitoxin Heptavalent, to treat symptomatic botulism after documented or suspected exposure to botulinum neurotoxin serotypes in adults and pediatric patients.

The drug gained approval under Health Canada's extraordinary use new drug regulations, which provide a regulatory pathway for products for which collecting information for use in humans is logistically or ethically not possible.

Emergent has an existing 10-year contract, executed in 2012, to supply the drug to the Canadian Department of National Defense, the Public Health Agency of Canada and individual provincial health authorities.

The company has also been supplying the drug to the U.S. Strategic National Stockpile as part of a $450 million contract with the Biomedical Advanced Research and Development Authority, within an office of the U.S. Department of Health and Human Services.