Medication Guide App

FDA Approves Generic Suboxone

Feb. 25, 2013 -- The United States Food and Drug Administration (FDA) has approved generic versions of Reckitt Benckiser Healthcare's Suboxone sublingual tablets. Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg will be produced by two U.S. based generic manufacturers - Actavis, Inc. and Amneal Pharmaceuticals, LLC.

Suboxone is indicated for maintenance treatment of opioid dependence.

For the 12 months ending December 31, 2012, Suboxone® tablets had total U.S. sales of approximately $625 million, according to IMS Health data. The generic equivalents are expected to save millions in healthcare costs.

Posted: February 2013


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