Food and Drug Administration approves a new Suboxone sublingual film product

by Admin

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On August 30, 2010, the Food and Drug Administration approved a new Suboxone sublingual film product. The sublingual film is approved for use in the
maintenance treatment of opioid dependence when used as part of a complete treatment plan to include counseling and
psychosocial support. Additional information on the approval requirements (post approval requirement for a clinical trial on
QT prolongation, Risk Evaluation and Mitigation Strategy) can be found in the FDA approval letter. Click here to view the
FDA approval letter. Information on the availability of the product may be found on the manufacturer”s website.
http://www.suboxone.com/hcp/Default.aspx.

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