Meda announced that the Food and Drug Administration (FDA) has approved Dymista (azelastine HCl and fluticasone propionate) for the relief of symptoms of seasonal allergic rhinitis (SAR) in patients ages 6–11 who require treatment with both components.
The safety and efficacy of Dymista was demonstrated in two pediatric clinical trials in children ages 6–11 with SAR who were treated with Dymistra (one spray per nostril twice daily). One trial was a two-week study comparing efficacy of Dymistra and placebo in 304 children and the other was a 12-week open-label trial comparing the safety of Dymista and fluticasone nasal spray in 353 children.
Dymista is a combination azelastine HCL and fluticasone propionate nasal spray formulation for the treatment of seasonal allergic rhinitis. It was previous indicated for use in children ages ≥12 and adults.
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