Meda Wins FDA Approval For Astepro

Meda has received FDA approval for Astepro (azelastine) nasal spray 0.15%, for the treatment of the symptoms of seasonal and perennial allergic rhinitis.

The 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.

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.

Anders Lonner, CEO of Meda, said: The approval of Astepro Once-Daily represents a significant milestone for Meda as we continue to expand our allergy treatment franchise. We are proud to introduce the first nasal antihistamine with once-daily dosing to the US. The launch is anticipated to begin in October 2009.”