Registration Application Submitted for Azelastine Extra Strength
Meda: Registration Application for Azelastine Extra Strength Submitted to the FDA
STOCKHOLM, Sweden--(BUSINESS WIRE)--Aug 4, 2008 - 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. Find out more, visit www.meda.se.
This information was brought to you by Cision http://newsroom.cision.com
Contact
Meda AB
Anders Larnholt, Vice President Investor Relations
tel. +46 8 630 19 62, +46 709 458 878
email: anders.larnholt@meda.se
Posted: August 2008
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.
