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Botox Approval History

FDA Approved: Yes (First approved December 9, 1991)
Brand name: Botox
Generic name: onabotulinumtoxinA
Dosage form: Injection
Company: Allergan plc
Treatment for: Chronic Spasticity, Hyperhidrosis, Cervical Dystonia, Migraine, Urinary Incontinence

Botox (onabotulinumtoxinA) is a neurotoxin complex indicated for the treatment of cervical dystonia, severe primary axillary hyperhidrosis (underam sweating), upper limb spasticity, lower limb spasticity, prevention of chronic migraine, urinary incontinence in people with neurologic conditions, and overactive bladder.

Development History and FDA Approval Process for Botox

DateArticle
Jan 22, 2016Approval FDA Approves Botox (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity
Jan 18, 2013Approval FDA Approves Botox to Treat Overactive Bladder
Aug 24, 2011Approval FDA Approves Botox to Treat Specific Form of Urinary Incontinence
Oct 15, 2010Approval FDA Approves Botox to Treat Chronic Migraine
Mar 10, 2010Approval Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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