Swedish pharmaceutical company Meda has submitted a marketing authorization application for Dymista azelastine hydrochloride/fluticasone propionate nasal spray for the treatment of moderate-to-severe allergic rhinitis and rhinoconjuctivitisto the EMA. An NDA for Dymista was submitted to the FDA in April 2011.
Meda CEO Anders Lönner said, “The regulatory filing for Dymista in Europe is important for our azelastine franchise. Earlier this year, Dymista was filed in the US and we will continue now with filings in other key markets.”
Meda currently markets two azelastine nasal sprays, Astelin and Astepro, in the US. In Europe, the company markets Astelin under several brands, including Allergodil and Rhinolast, and an MAA for Astepro was submitted in October 2010.
Read the Meda press release.
