Meda has announced that its Astepro azelastine nasal spray for the treatment of allergic rhinitis has received registration approval in Europe through the centralized procedure and that it will now begin the national registration processes in individual countries in anticipation of a 2013 launch. Earlier this year, Meda filed suit against Apotex and Perrigo in the US for patent infringement after Perrigo filed an ANDA for a generic version of Astepro.
Meda CEO Anders Lönner said, “We are pleased to announce the approval of Astepro in Europe. The product has been launched in the US with good success. With the addition of Dymista, currently in registration phase, Meda will have an extraordinary strong position in the allergy rhinitis area, both in the US and Europe.”
The company filed an NDA for Dymista, an azelastine and fluticasone nasal spray, in April 2011 and an MAA for the product in October of that year.
Read the Meda press release.
