FDA has accepted for filing the first potential once-a-day nasal antihistamine

FDA has accepted for filing the first potential once-a-day nasal antihistamine 

The New Drug Application (NDA) for a newly formulated higher strength azelastine
nasal spray has now been accepted by the Food and Drug Administration (FDA) as
complete for substantive review after initial evaluation.

“This product has the potential to become the first once-a-day nasal
antihistamine in the U.S. Beside better tolerance with the new formulation it
could also mean better compliance for patients. The product would contribute
significantly to Meda's allergy franchise”, said Anders Lönner, CEO Meda.

Meda has completed six phase III studies and a long-term safety study, involving
more than 1,600 patients in total. In these clinical studies, the product
demonstrated improvement in nasal symptom relief scores in patients with
seasonal and perennial allergic rhinitis, and was well tolerated.


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.