Impax Specialty Pharma has received approval from the FDA to market Zomig zolmitriptan nasal spray for the treatment of migraine in patients 12-17 years of age, the company says. Impax acquired the US rights to Zomig nasal spray from AstraZeneca in 2012.
Impax Laboratories President and CEO Fred Wilkinson commented, “Treatment options have been limited for pediatric patients and we are pleased with FDA’s decision and look forward to bringing migraine relief to pediatric patients by making Zomig nasal spray available to this ‘school age’ patient population. This expanded indication exemplifies our strategy to broaden the reach of our current product portfolio to address unmet needs in underserved therapeutic areas, thereby adding value for patients and shareholders alike.”
The nasal spray has been approved in the US for the treatment of migraine in adults since 2003. An sNDA requesting approval to market Zomig nasal spray to adolescents was submitted in 2007. The FDA’s Pediatric Advisory Committee also reviewed the use of Zomig nasal spray in this age group in 2011.
Read the Impax press release.
