Table 1.

Approved indications for onabotulinumtoxinA in the USA and Europe

Year of FDA approval	Indication	Typical age ranges*	Indication statement approved by FDA1, 2	Year of EU approval†
1989	Strabismus	Commonly in first decade of life35	Treatment of strabismus in patients ≥12 years of age	N/A
1989	Blepharospasm	Onset in 50s,36 with prevalence increasing with age37	Treatment of blepharospasm associated with dystonia in patients ≥12 years of age	1994
2000	Cervical dystonia	Onset in early 40s38, 39, 40	Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain	1995
2002‡	Glabellar lines	Mean age of onset, 46.4 ± 9.9 years41	Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugators and/or procerus muscle activity in adult patients	2003
2004	Primary axillary hyperhidrosis	Onset in mid‐20s, with highest prevalence of 3.5–4.5% among those aged 25–64 years42	Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients	2001
2010	Focal upper limb spasticity	Prevalence of stroke increases with age: 4.8% among those aged 65–84 years and 7.1% in those >75 years.43 At 12 months post‐stroke, prevalence of upper limb spasms is 17–19%	Treatment of upper limb spasticity in adult patients	2001
2010	Chronic migraine	Peak prevalence in 40s at 1.9% for females; 0.8% for males44	Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 h or longer per day)	2010
2011	Detrusor overactivity associated with a neurologic condition	Mean age 62.5 years among NDO patients in a US claims database45	Treatment of urinary incontinence because of detrusor overactivity associated with a neurologic condition (e.g., spinal cord injury, multiple sclerosis) in adults who have an inadequate response to or are intolerant of an anticholinergic medication	2011
2013	Overactive bladder	Age group with highest prevalence: ≥60 years (19.1% in females; 8.2% in males)46	Treatment of overactive bladder with symptoms of urgency urinary incontinence, urgency, and frequency in adults who have an inadequate response to or are intolerant of an anticholinergic medication	2013
2013‡	Lateral canthal lines	Mean age of onset, 46.4 ± 9.9 years41	Temporary improvement in the appearance of moderate to severe lateral canthal lines associated with orbicularis oculi activity in adult patients	2014
N/A	Juvenile cerebral palsy dynamic equinus foot deformity	Appears in infancy or childhood	N/A	1997
N/A	Lower limb spasticity	Prevalence of stroke increases with age: 4.8% among those aged 65–84 years and 7.1% in those >75 years.43 At 12 months post‐stroke, prevalence of lower limb spasms is 11–32%	N/A	2014

EU = European Union, FDA = Food and Drug Administration, N/A = not applicable, NDO = neurogenic detrusor overactivity.

Table is adapted from Brin MF, Blitzer A. History of onabotulinumtoxinA therapeutic. In Botulinum Toxin. Carruthers J and Carruthers A (eds). 3rd edition. London: Elsevier Saunders, 2013:6–12.

^* The mean age of onset for the cosmetic indications is based on treatment data.41 For all other indications, the data are as published in the literature, and not necessarily representative of the population being treated.

^† First EU approval in UK or Ireland /France. (Reference Member State of the Mutual Recognition Process for Therapeutic/Aesthetic respectively). Specific indications often vary from those licensed in the USA.

^‡ As BOTOX^® Cosmetic.