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BAT is the only FDA-approved product available for treating botulism in adults, and for botulism in infants caused by botulinum toxins other than types A and B. BAT has been used to treat a case of type F infant botulism and, on a case-by-case basis, may be used for future cases of non-type A and non-type B infant botulism.
Botulinum toxin, or botulinum neurotoxin (commonly called botox), is a neurotoxic protein produced by the bacterium Clostridium botulinum and related species. [24] It prevents the release of the neurotransmitter acetylcholine from axon endings at the neuromuscular junction , thus causing flaccid paralysis . [ 25 ]
Along with some strains of Clostridium butyricum and Clostridium baratii, these bacteria all produce the toxin. [2] Botulinum toxin can cause botulism, a severe flaccid paralytic disease in humans and other animals, [3] and is the most potent toxin known to science, natural or synthetic, with a lethal dose of 1.3–2.1 ng/kg in humans. [4] [5]
Allergan plc is an American, Irish-domiciled pharmaceutical company that acquires, develops, manufactures and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. [1] [2] [3] The company is the maker of Botox. [1]
This generally only occurs with inappropriate strengths of botulinum toxin for cosmetic use or due to the larger doses used to treat movement disorders. [2] However, there are cases where an off-label use of botulinum toxin resulted in severe botulism and death. [25] Following a 2008 review the FDA added these concerns as a boxed warning. [26]
The origins of Galderma date back to 1961 and the founding of the Owen dermatology company in Dallas, Texas, USA by M. Owen. [5]. In 1979, Hans Schaefer founded the International Center for Dermatological Research (CIRD) in Sophia Antipolis, with the support of the CEO of L'Oréal, François Dalle, who wanted to diversify his cosmetic research into the drug sector.
Torticollis patients discovered that their pain could be markedly reduced, motility increased, and head position improved by toxin injection. But, in 1986, Oculinum Inc, Scott's micromanufacturer and distributor of botulinum toxin, was unable to obtain product liability insurance, and could no longer supply the drug.
Absence of neurotoxin production has been demonstrated by polymerase chain reaction (PCR) and Southern blot hybridisation for type E botulinum toxin gene. The absence of genes encoding botulinum neurotoxin A,B,F and genes encoding non-toxic haemagglutinin (NTNH) and genes encoding Clostridium perfringens toxins (alpha, beta, epsilon and iota ...