Botox FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 20, 2024.

FDA Approved: Yes (First approved December 9, 1991)
Brand name: Botox
Generic name: onabotulinumtoxinA
Dosage form: Injection
Company: AbbVie Inc.
Treatment for: Hyperhidrosis, Cervical Dystonia, Urinary Incontinence, Migraine Prevention, Upper Limb Spasticity, Lower Limb Spasticity, Blepharospasm, Strabismus, Spasticity, Neurogenic Bladder

Botox (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of overactive bladder, urinary incontinence, prophylaxis of headaches in adult patients with chronic migraine, spasticity, cervical dystonia, axillary hyperhidrosis, blepharospasm, and strabismus.

Botox (onabotulinumtoxinA) is 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
treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of 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 spasticity in patients 2 years of age and older
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 timeline for Botox

Date	Article
Jul 29, 2021	Approval FDA Approves Expanded Botox (onabotulinumtoxinA) Label to Include Eight New Muscles to Treat Adults with Upper Limb Spasticity
Feb 10, 2021	Approval Botox (onabotulinumtoxinA) Receives FDA Approval for Pediatric Detrusor Overactivity Associated with a Neurologic Condition
Jul 9, 2020	Approval FDA Approves Expanded Botox (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
Oct 24, 2019	Approval FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Lower Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy
Jun 21, 2019	Approval FDA Approves Botox (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
Jan 22, 2016	Approval FDA Approves Botox (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity
Jan 18, 2013	Approval FDA Approves Botox to Treat Overactive Bladder
Aug 24, 2011	Approval FDA Approves Botox to Treat Specific Form of Urinary Incontinence
Oct 15, 2010	Approval FDA Approves Botox to Treat Chronic Migraine
Mar 10, 2010	Approval Botox (onabotulinumtoxinA) Receives FDA Approval for Treatment of Upper Limb Spasticity in Adults

Further information

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Medical Disclaimer

Drug Status

Availability Prescription only Rx

Pregnancy & Lactation Risk data available

CSA Schedule* Not a controlled drug N/A

Approval History Drug history at FDA

Botox FDA Approval History

Development timeline for Botox

See also

Further information