Impax Specialty Pharma, a division of Impax Laboratories, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Zomig nasal spray for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.

Zomig nasal spray is the first nasal-delivered prescription medicine approved for the treatment of acute migraine attacks in pediatric patients. Nasal sprays may offer an alternative method of administration when patients experience migraine-associated nausea, have difficulty taking oral formulations, or do not have liquids available. 

Zomig nasal spray's approval came after the FDA's review of safety and efficacy data from pivotal clinical trials demonstrating that Zomig nasal spray 5 mg is significantly more effective than placebo in providing no headache pain, relief of headache, and other associated symptoms of migraine when treating migraine in pediatric patients. In clinical trials, the medication also had a safety profile similar to that demonstrated in adults. For full safety and efficacy information, please see the prescribing information.

For more details, go to: http://investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release-Details/2015/FDA-Approves-ZOMIG-zolmitriptan-Nasal-Spray-for-Migraine-in-Pediatric-Patients-Ages-12-17/default.aspx