Actavis obtains final approval from FDA for generic Subutex

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Feb 21 2015

Actavis plc (NYSE: ACT) today announced that it has received final approval from the U.S. Food and Drug Administration on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex® (Buprenorphine 2 mg and 8 mg sublingual tablets). Actavis intends to begin shipping its product shortly.

Subutex® is indicated for the treatment of opioid dependence. For the 12 months ending December 31, 2014, Subutex® had total U.S. sales of approximately $108 million, according to IMS Health data.

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Actavis plc

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