U.S. License Holder:
Allergan
Date of License:
December-09-1991
Last Update:
Sep-30-2024
FDA-Approved Indications
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;
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 or more 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 or older;
Treatment of strabismus in patients 12 years of age or older.
BOTOX COSMETIC is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of:
Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity;
Moderate to severe lateral canthal lines associated with orbicularis oculi activity;
Moderate to severe forehead lines associated with frontalis muscle activity.