Botox FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 15, 2021.
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, 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
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