Meda: FDA Approval of the First Once-Daily Nasal Antihistamine
STOCKHOLM, Sep 02, 2009 (BUSINESS WIRE) ----Regulatory News:
Meda AB (STO:MEDAA)
The U.S. Food and Drug Administration (FDA) has approved Astepro (azelastine) nasal spray 0.15% for the treatment of the symptoms of seasonal and perennial allergic rhinitis. This new Astepro nasal spray 0.15% ("Astepro Once-Daily") is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies. Astepro Once-Daily is formulated with azelastine, a leading nasal antihistamine in the treatment of rhinitis in the U.S. "The approval of Astepro Once-Daily represents a significant milestone for Meda as we continue to expand our allergy treatment franchise," said Anders Lonner, CEO Meda. "We are proud to introduce the first nasal antihistamine with once-daily dosing to the U.S. The launch is anticipated to begin in October 2009."
The FDA approval was based primarily on the results of seven double-blind, placebo-controlled Phase III clinical trials, and a long-term, 12-month safety trial, conducted in more than 2,300 patients with seasonal and perennial allergic rhinitis.
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 more than 40 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.