FDA requests more information on new azelastine formulation


FDA requests more information on new azelastine formulation

The U.S. Food and Drug Administration (FDA) has requested more information on
Meda's new drug application concerning azelastine hydrochloride nasal spray in a
new formulation. Meda will initiate a discussion with the FDA to understand and
clarify the needs of FDA and what steps need to be taken before the application
may be approved. This process is anticipated to take several months before
conclusion.


For more information, please contact:

Anders Larnholt, 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.  

Attachments

06032674.pdf