Registration Application For Azelastine Extra Strength Submitted To The FDA

Main Category: Allergy
Also Included In: Respiratory / Asthma;  Regulatory Affairs / Drug Approvals
Article Date: 05 Aug 2008 - 0:00 PDT

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The registration application for azelastine nasal spray in the new formulation with Extra Strength has been submitted to the US Food and Drug Administration (FDA), seeking 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 a 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.

MEDA AB (publ) is an international specialty pharma company that concentrates on marketing and market-adapted product development. Acquisitions and long-term partnerships are fundamental factors that drive the company's strategy. Meda is represented with own organisations in 26 countries and with more than 1 500 employees within marketing and sales. Meda's products are sold in approximately 120 countries world-wide. The Meda share is listed under Large Cap on the OMX Nordic Stock Exchange.

http://www.meda.se