What are the FDA approved indications for botulinum toxin (BoNT)?

Updated: Jul 13, 2018
  • Author: Divakara Kedlaya, MBBS; Chief Editor: Elizabeth A Moberg-Wolff, MD  more...
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Answer

Answer

The various botulinum toxins possess individual potencies, and care is required to assure proper use and avoid medication errors. Recent changes to the established drug names by the FDA were intended to reinforce these differences and prevent medication errors. The products and their approved indications include the following:

  • OnabotulinumtoxinA (Botox®, Botox Cosmetic®)

    • Botox® - Cervical dystonia, severe primary axillary hyperhidrosis, strabismus, blepharospasm, neurogenic detrusor overactivity, chronic migraine, upper limb spasticity

    • Botox Cosmetic® - Moderate to severe glabellar lines, moderate to severe lateral canthal lines, known as crow’s feet

  • AbobotulinumtoxinA (Dysport®) - Upper and lower limb spasticity, cervical dystonia, and moderate-to-severe glabellar lines in adults; it is also indicated for lower limb spasticity in children aged 2 years or older

  • IncobotulinumtoxinA (Xeomin®) - Upper limb spasticity, cervical dystonia, blepharospasm, moderate to severe glabellar lines, chronic sialorrhea

  • RimabotulinumtoxinB (Myobloc®) - Cervical dystonia


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