FDA approves Botox for pediatric patients suffering from upper limb spasms
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Allergan announced that the U.SFood andDrug(http://Administration (
FDA(http://) has approved Botox (patox, generic name: onabotulinumtoxinA, Botox Toxin A) for the treatment of pediatric patients suffering from upper limb spasms (2-17 years old), the condition approved through the FDA's priority review process, the FDA is also reviewing Botox's supplementary biologics (sBLA) for the treatment of pediatric patients with lower limb spasms, and is expected to make a review decision in the fourth quarter of this yearThe approval makes Botox the first neurotoxin therapy for upper limb spasms in pediatric patients and marks Botox's 10th approved treatment for adaptations in its 30th year on the marketthe approval is based on data from two Phase III clinical studies that assessthe safety and efficacy of Botox in more than 200 pediatric patients with upper limb spasms, including a 12-week double-blind study and a one-year open label extension studyBotoxBotox is also the first FDA-approved neurotoxin therapy for upper and lower limb spasms in adults 18 years of age and olderBotox was developed by El-Jian, the main ingredient of the drug is the highly purified Botox A toxin, a nerve-conducting blocker used to treat overactive musclesBotox was first approved in 1989 to treat face spasms and squint, approved for neck dystonia in 2000, and has since expanded into the beauty field, including wrinkle removal, thin face, brow and fishtailBotox has also been approved for treatment of a variety of indications such as upper limb spasms, chronic migraines, neuroincontinence, and bladder hyperactivity
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