Meda announces the approval by FDA (U.S. Food and Drug Administration) of Dymista, a single formulation azelastine hydrochloride and fluticasone propionate nasal spray 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.

For more details, go to: http://feed.ne.cision.com/wpyfs/00/00/00/00/00/2B/76/25/release.html