FDA approves a license application for complementary biologics from Airbnb Botox
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Last Update: 2020-06-07
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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 a supplementary biologic license application (sBLA) for Botox (patos," generic name: onabotulinumtoxinA, Botox toxin A) to treat pediatric patients with lower limb spasms (2-17 years old), which does not include cerebral palsy.comThe approval, based on data from theof a Phase III ClinicalTrial(http:// was conducted in more than 300 pediatric patients (2-17 years old) with lower limb spasms to assess the safety and efficacy of Botox treatmentAlthough the trial participants included people with cerebral palsy, Botox's approved indication spree excluded lower limb spasms caused by cerebral palsy, thanks to market dominance of(http://, anothercompany For treatment, the recommended recommended dose for each treatment of Botox is 4 units per kg to 8 units per kilogram, distributed to the affected muscles of the lower extremities The total dose per treatment of the lower extremities should not exceed 8 units or 300 units per kilogram, whichever is lower When treating lower or upper limbs at the same time, the total dose of the child patient should not exceed 10 units or 340 units per kilogram of body weight, whichever is lower, at intervals of 3 months About Botox Botox (Patox) developed by Ayr, the main ingredient of the drug is the highly purified Botox A toxin, a nerve-conductive blocker used to treat overactive muscles Botox 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 fishtail In recent years, Botox has also been approved to treat a variety of indications such as upper limb spasms, chronic migraines, neuroincontinence, and bladder hyperactivity
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