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Actavis' generic Suboxone receives FDA approval

March 7, 2013
by Shannon Brys, Associate Editor
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Actavis, Inc. has announced that it has received approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Buprenorphine HCl and Naloxone HCl Dihydrate SL Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the generic equivalent to Reckitt Benckiser Healthcare's Suboxone.  

For the 12 months ending December 31, 2012, Suboxone tablets had total U.S. sales of approximately $625 million, according to IMS Health data.