Actavis' generic Subutex approved

DUBLIN - Actavis on Friday announced that it has received final approval from the 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 Dec. 31, 2014, Subutex had total U.S. sales of approximately $108 million, according to IMS Health data.