The FDA approves Astepro

The FDA approves Astepro 

The U.S. Food and Drug Administration (FDA) has approved Astepro - the new
formulation of Astelin. Astepro Nasal Spray is an improvement over the marketed
Astelin Nasal Spray and is better tolerated by patients using the new spray. The
active substance in these products is azelastine - the leading nasal
antihistamine in the treatment of rhinitis in the U.S. 

Astepro is now approved for treatment of seasonal allergic rhinitis. Fewer
reports of bitter taste and nasal discomfort were recorded by Astepro users and
it was in general better tolerated than Astelin. Symptom relief, as recorded by
patients, was also better. In total, about 1,400 patients were involved in
Meda's phase III studies.

“Our development team has done an excellent work answering the questions from
FDA and reaching approval in such a short time. This is an important milestone
for Meda”, said Anders Lönner, CEO Meda. 

Full launch of Astepro in the U.S. will take place well before the next allergic
rhinitis season.


For more information, please contact:

Anders Larnholt, Vice President Investor Relations, tel. +46 709 458 878


MEDA AB (publ) is a leading international specialty pharma company. The company
specialises in marketing and pharmaceutical development in late clinical stage.
Acquisitions and long-term partnerships are fundamental factors that drive the
company's strategy. Meda is represented by its own organisations in about 40
countries. Meda's products are sold in 120 countries worldwide. The Meda share
is listed under Large Cap on the OMX Nordic Stock Exchange. Find out more, visit
www.meda.se.