According to Meda, the EU has approved the company’s Dymista azelastine/fluticasone nasal spray for the treatment of seasonal and perennial allergic rhinitis. Meda submitted an MAA for the product in late 2011. The company announced the FDA’s approval of Dymista in May 2012.
The European approval was made through the decentralized procedure, and Meda says that it expects to complete the national registration process in “several” countries in time to launch Dymista in 2013.
Meda AB CEO Anders Lönner commented, “Patients in Europe that suffer from allergic rhinitis will soon have access to a better treatment option than the current standard therapy. The faster and more complete effect offers significant benefit to the growing numbers of patients suffering from this difficult and inhibiting disease.”
Read the Meda press release.
