Botox Approved for New Indication

January 21, 2016 – The U.S. Food and Drug Administration (FDA) approved Botox (onabotulinumtoxinA - Allergan), to reduce increased muscle stiffness in the ankles and toes of adult patients with lower limb spasticity. Spasticity problems with muscles in the feet and lower legs can also occur in individuals who have had a stroke or spinal cord injury, as well as those with a chronic condition, such as multiple sclerosis. Dosing is 300 units to 400 units divided into several injections given into the large muscle groups at the back of the affected legs. Treatments may be repeated as often as every 12 weeks.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.