Onsolis approved in Canada

The New Drug Submission (NDS) for Onsolis (fentanyl buccal soluble film) has been approved by the Canadian regulatory authority, Health Canada. Onsolis is a new and patented product 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 will be the first available fentanyl product with rapid onset of action approved in Canada and is expected to be available for patients during the third quarter 2010. The product will be commercialized by the joint venture between Meda and Valeant (Meda Valeant Pharma Canada Inc.). About Onsolis 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.



wkr0011.pdf