Meda: FDA Approval For Onsolis Anticipated During Summer 2009

Main Category: Cancer / Oncology
Also Included In: Pain / Anesthetics;  Regulatory Affairs / Drug Approvals
Article Date: 16 Jun 2009 - 0:00 PDT

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Since August 2008, Meda (STO:MEDAA) and BioDelivery Sciences International (BDSI) have worked in close collaboration with the U.S. Food and Drug Administration (FDA) to complete the final requirement of a Risk Evaluation and Mitigation Strategy (REMS) program for Onsolis (fentanyl - treatment of breakthrough cancer pain).

Last Friday, FDA's review Division informed Meda and BDSI that they had reached agreement with the REMS for Onsolis, but that the FDA needed some additional time to complete the final senior level sign off. Meda therefore expects Onsolis to be approved by the FDA during summer, which could enable a fourth quarter 2009 launch, as previously anticipated.

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 drive the company's strategy. Meda is represented by its own organizations in about 40 countries. Meda's products are sold in 120 countries worldwide. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange Stockholm. Find out more, visit http://www.meda.se.

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MEDA AB