FDA approval of the first once-daily nasal antihistamine

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 Lönner, 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.

About Us

Meda is one of Europe's leading specialty pharma companies, with focus on marketing and market-adapted product development. Long-term partnerships and acquisitions are fundamental factors in its strategy.


Documents & Links