Botulism approval
March 25, 2013
THE US Food and Drug
Administration has approved
Botulism Antitoxin Heptavalent (A,
B, C, D, E, F, G)-(Equine) to treat
patients showing signs of botulism
following documented or suspected
exposure to botulinum neurotoxin.
The product is derived from horse
plasma and contains a mixture of
antibody fragments that neutralize
all of the seven botulinum nerve
toxin serotypes known to cause
botulism.
“This product approval meets an
urgent unmet medical need for the
treatment of sporadic cases of lifethreatening
botulism and provides
a medical countermeasure should
botulinum nerve toxins be used in a
terrorism event,” said Karen
Midthun, M.D., director of the
FDA’s Center for Biologics
Evaluation and Research.
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