Actavis gains final FDA approval for generic Subutex

February 23, 2015

Actavis has received final approval from FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2 mg and 8 mg sublingual tablets) indicated for treatment of opioid dependence.

Actavis has received final approval from FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2 mg and 8 mg sublingual tablets) indicated for treatment of opioid dependence.

For the 12 months ending December 31, 2014, Subutex had total US sales of approximately $108 million, according to IMS Health data.

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“Drug overdose deaths are the leading cause of injury and death in the United States today,” according to Miles Varn, MD, chief medical officer at PinnacleCare. “This is clearly a health crisis. Subtex is an effective treatment for those suffering narcotic addiction, but one of the huge barriers has been cost-$200 to $500 per month. A generic alternative clearly lower the cost and hopefully prompt more patients to seek treatment and avoid an unintended overdose.”

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