Source:

Press Release

July 29, 2021
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FDA approves Botox label expansion for adult upper limb spasticity

Source:

Press Release

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The FDA has approved a label expansion for Botox to include eight new muscles and the use of ultrasound for the treatment of upper limb spasticity in adults, according to a press release.

Botox (onabotulinumtoxinA, Allergan, an AbbVie company) is designed to treat adult upper limb spasticity, which is commonly caused by stroke, multiple sclerosis, spinal cord injury, cerebral palsy and traumatic brain injury, according to the release.

With more than 10 years of clinical use and an established safety profile, onabotulinumtoxinA is now expanded for use in the brachialis, brachioradialis, pronator teres, pronator quadratus, lumbricals, interossei, flexor pollicis brevis and opponens pollicis. OnabotulinumtoxinA is also expanded to use ultrasound as a muscle localization technique, according to the release.

“Today's announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient's quality of life,” Mitchell F. Brin, MD, senior vice president and chief scientific officer of Botox and Neurotoxins at AbbVie, said in the release. “This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of Botox in upper limb spasticity treatment. Botox provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients,” Brin added.