FDA approves onabotulinumtoxinA to prevent chronic migraine

FDA approves onabotulinumtoxinA to prevent chronic migraine

November 12, 2010

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine.

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine. OnabotulinumtoxinA is injected about every 12 weeks at multiple sites around the head and neck to try to dull future headache symptoms.

Irvine, Calif.-based Allergan provided FDA substantial evidence of safety and effectiveness to support the new indication of prophylaxis of headaches in patients with chronic migraine, an agency spokesperson told Formulary.

Botox has not been shown to work for the treatment of migraine headaches that occur 14 days or less per month or for other forms of headache.