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Actavis gains final FDA approval for generic Subutex
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.
Related: FDA approves abuse-deterrent labeling for Embeda
“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.”
Read next: Study: Many opioid users are taking Rx drugs in potentially harmful combinations; education needed
