The FDA has approved Meda’s Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis in children aged 6-11 “who require treatment with both components,” the company said. Dymista was approved for adults and for children 12 and older in 2012.
Meda submitted data from two pediatric trials to support the safety and efficacy of Dymista in children 6-11. One trial was a two-week study that compared Dymista to placebo; the other was a 12-week open label trial that compared the safety of Dymista to fluticasone only nasal spray.
Read the Meda press release.
