The New Drug Application (NDA) for Dymista has been accepted by the U.S. Food and Drug Administration (FDA) as sufficiently complete to permit a substantive review.
Dymista is a new product for treatment of allergic rhinitis. Efficacy and safety of Dymista has been documented in several studies involving over 4,000 patients, including a long term safety study with more than 600 patients.
“An important step has been reached for Dymista. Dymista could improve the treatment of allergic rhinitis which is a growing problem. Dymista has in clinical studies shown faster and better effect than standard nasal treatment”, says Anders Lönner, CEO of Meda.
For further inquiries, please contact:
Anders Larnholt, Vice President Corporate Development & IR ph: 46 709-458 878
MEDA AB (publ) is a leading international specialty pharma company. Meda’s products are sold in 120 countries worldwide and the company is represented by its own organizations in 50 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit www.meda.se.