Onsolis filed in Canada

The registration file for Onsolis (fentanyl buccal soluble film) has been submitted to the Canadian regulatory authority; Health Canada. If approved, it may become the first available fentanyl product approved for breakthrough pain in opioid tolerant patients with cancer in Canada. A decision by Health Canada is expected during 2010. Canada represents an important market for Onsolis. The product will be commercialized by the joint venture between Meda and Valeant (Meda Valeant Pharma Canada Inc.). About Onsolis Onsolis is a new and patented product, indicated for the management of breakthrough pain in cancer patients who are tolerant to opioid therapy. 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. Onsolis has been approved in the US and launch is expected to begin this month. In Europe, Onsolis is under regulatory review with approval expected in 2010.

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