BOTOX(R) (onabotulinumtoxinA) Receives U.S. Food And Drug Administration Approval For The Treatment Of Overactive Bladder For Adults Who Have An Inadequate Response To Or Are Intolerant Of An Anticholinergic Medication
About BOTOX® (onabotulinumtoxinA)BOTOX® is a prescription-only medical product that contains tiny amounts of a highly purified botulinum toxin protein refined from the bacterium, Clostridium botulinum. The BOTOX® formula contains auxiliary proteins that stabilize the core toxin in BOTOX® from degradation. When injected at doses approved by the FDA into a specific muscle or gland, BOTOX® neurotoxin is expected to act locally to produce a safe and effective result, usually lasting between three to ten months depending on the approved indication and on the individual patient.
BOTOX® was first approved by the FDA more than 22 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Today, BOTOX® neurotoxin is approved to treat a total of eight medical conditions in the United States, including the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults; symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough; for the treatment of increased muscle stiffness in elbow, wrist, and finger muscles in adult patients with upper limb spasticity; for the prophylactic treatment of headaches in adults with Chronic Migraine, a distinct and severe neurological disorder characterized by patients who have a history of migraine and suffer from headaches on 15 or more days per month with headaches lasting four hours a day or longer; for the 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; and for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant of an anticholinergic medication.
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