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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: Hyperhidrosis, Cervical Dystonia, Urinary Incontinence, Migraine Prevention, Upper Limb Spasticity, Lower Limb Spasticity, Blepharospasm, Strabismus

Botox (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

  • treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication
  • treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication
  • prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer)
  • treatment of upper and lower limb spasticity in adult patients
  • treatment of upper limb spasticity in pediatric patients 2 to 17 years of age
  • treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain
  • treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients
  • treatment of blepharospasm associated with dystonia in patients 12 years of age and older
  • treatment of strabismus in patients 12 years of age and older.

Development History and FDA Approval Process for Botox

DateArticle
Jun 21, 2019Approval FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
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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