FDA extends indication of Dymista in Allergic Rhinitis-Meda AB

The FDA has approved Dymista (azelastine hydrochloride and fluticasone propionat), from Meda AB, for the relief of symptoms of seasonal allergic rhinitis in patients 6-11 years of age who require treatment with both components. Dymista was previously indicated only for adults and children 12 and older. The approved dosing for Dymista in children 6 to 11 is 1 spray/nostril BID (same as the dosing for adolescents and adults with SAR).

The efficacy and safety of Dymista was demonstrated in 2 pediatric trials where children 6 to 11 were treated with Dymista (1 spray per nostril twice daily). One of these trials was a 2-week trial comparing efficacy of Dymista and placebo in 304 children 6 to 11 years of age with SAR. The other trial was a 12-week open-label trial comparing the safety of Dymista and fluticasone nasal spray in 353 children 6 to 11 years of age with allergic rhinitis. The efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including long-term safety studies with more than 600 patients 12 years and older and in more than 350 patients aged 6 to 11 years.