Actavis receives final FDA approval for generic version of Subutex

Ireland-headquartered generics major Actavis (NYSE: ACT) has received final approval from the US Food and Drug Administration on its Abbreviated New Drug Application for a generic version of the UK-based consumer goods giant Reckitt Benckiser's (LSE: RB) Subutex (buprenorphine 2mg and 8mg sublingual tablets).

Actavis said that it intends to begin shipping its product shortly.

Subutex, which is now part of the RC Pharmaceuticals business spun-out at the end of last year under the company name Indivior (LSE: INDV), is indicated for the treatment of opioid dependence. For the 12 months ending December 31, 2014, Subutex had total US sales of about $108 million, according to IMS Health data quoted by Actavis.