Registration application for azelastine Extra Strength submitted to the FDA

Registration application for azelastine Extra Strength submitted to the FDA 

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.

For more information, please contact:

Anders Larnholt, Vice President Investor Relations, tel. +46 8 630 19 62, +46
709 458 878
email: anders.larnholt@meda.se

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.