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DESCRIPTION BOTOX® Cosmetic (onabotulinumtoxinA) for injection, is a sterile, vacuum dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A grown in a medium containing casein hydrolysate, glucose, and yeast extract, intended for intramuscular use. It is purified from the culture solution by dialysis and a series of acid precipitations to a complex consisting of the neurotoxin, and several accessory proteins. The complex is dissolved in sterile sodium chloride solution containing Albumin Human and is sterile filtered (0.2 microns) prior to filling and vacuum-drying. One Unit of BOTOX® Cosmetic corresponds to the calculated median intraperitoneal lethal dose (LD50) in mice. The method utilized for performing the assay is specific to Allergan’s product BOTOX® Cosmetic. Due to specific details of this assay such as the vehicle, dilution scheme and laboratory protocols for the various mouse LD50 assays, Units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into Units of any other botulinum toxin or any toxin assessed with any other specific assay method. In addition, differences in species sensitivities to different botulinum neurotoxin serotypes precludes extrapolation of animal-dose activity relationships to human dose estimates. The specific activity of BOTOX® Cosmetic is approximately 20 units/nanogram of neurotoxin protein complex. Each vial of BOTOX®Cosmetic contains either 100 Units of Clostridium botulinum type A neurotoxin complex, 0.5 mg of Albumin Human, and 0.9 mg of sodium chloride or 50 Units of Clostridium botulinum type A neurotoxin complex, 0.25 mg of Albumin Human, and 0.45 mg of sodium chloride in a sterile, vacuum-dried form without a preservative.
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