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AbbVie : FDA Oks Expanded BOTOX Label To Include Eight New Muscles To Treat Upper Limb Spasticity

Allergan, an AbbVie (ABBV) company, said that the U.S. Food and Drug Administration has approved a label expansion of BOTOX to include eight new muscles for the treatment of upper limb spasticity in adults.

The new muscles for treatment include additional muscles of the elbow and forearm, as well as intrinsic hand muscles and thumb muscles. The label now includes the use of ultrasound as a muscle localization technique in adult spasticity.

BOTOX has been proven to significantly reduce muscle stiffness and is indicated for the treatment of spasticity in patients 2 years of age and older. The safety profile of BOTOX in adult upper limb spasticity remains the same, with the most common adverse reactions including nausea, fatigue, bronchitis, pain in extremity and muscular weakness.

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