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news.Meda has submitted the registration application to the FDA for azelastine nasal spray in the new formulation with extra strength.
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The application seeks approval to treat symptoms of seasonal allergic rhinitis and perennial allergic rhinitis. The new formulation is patent pending.
Six Phase III studies evaluating efficacy and safety and long term safety have been conducted involving about 1,600 patients treated with azelastine extra strength. The higher strength has been shown to offer additional symptom relief with maintained safety profile.
In addition, the application seeks approval of a once or twice daily treatment regimen.