Onsolis receives FDA approval

Onsolis receives FDA approval 

The U.S. Food and Drug Administration (FDA) has approved Onsolis (fentanyl
buccal soluble film). This new and patented product is indicated for the
management of breakthrough pain in cancer patients who are already receiving and
who are tolerant to opioid therapy for their underlying persistent cancer pain.
Onsolis uses a unique delivery system designed to give rapid and reliable
delivery of fentanyl. The product consists of a small dissolvable disc for
application of fentanyl to the buccal (inner lining of cheek) membranes. The
product is unique and offers an important step to a better pain treatment of
cancer patients.

“I'm very pleased that Onsolis has been approved for marketing in the U.S. For
Meda in the U.S., we get yet another important product addition. The interest
among specialists for this new technology is significant, and we are making
preparations for product launch during the fourth quarter of 2009. The
registration procedures for Onsolis in other key markets are progressing
according to plan”, said Anders Lönner, CEO Meda. 

Meda has, in close collaboration with the FDA and Meda's development partner
BioDelivery Sciences Inc, developed the REMS (Risk Evaluation and Mitigation
Strategy) program for Onsolis. This REMS program has also been approved by the
FDA.

For more information contact:

Anders Larnholt, VP Corporate Development & Investor Relations	tel. +46 709 458
878

MEDA AB (publ) is a leading international specialty pharma company. Meda's
products are sold in 120 countries worldwide and the company is represented by
its own organizations in more than 40 countries. The Meda share is listed under
Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more,
visit www.meda.se.