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2002
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US FDA Marketing Approval for Reckitt Benckiser's Subutex« & Suboxone«
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Announcements
RB Press release - 09/10/2002
US FDA Marketing Approval for Reckitt Benckiser's Subutex« & Suboxone«
Reckitt Benckiser plc announced today that its new treatments for opiate dependence, SuboxoneÔ (buprenorphine/naloxone) and SubutexÔ (buprenorphine) 2mg and 8mg tablets have been approved by the US Food and Drug Administration for the treatment of opiate dependence. These products were developed under a Cooperative Research and Development Agreement between Reckitt Benckiser and the National Institutes of Health's National Institute on Drug Abuse in the USA over the past ten years.
Subutex and Suboxone will become useful additions to the available range of pharmacotherapies that can help opiate-dependent patients overcome their addiction. The major benefit of Subutex/Suboxone is that qualified physicians in the US will now be able to treat patients with these products in the privacy of the Doctor's office rather than only from the limited number of existing drug treatment programs.
Subutex first received marketing approval in France and was launched in February 1996 by Schering-Plough under licence from Reckitt Benckiser. Since then the product has been launched in 24 countries. Licence income from these sales forms a modest but growing contribution to Reckitt Benckiser's core Health & Personal Care category.
To view the full press release, click on the icon to download the pdf.
news_091002_usfdaapproval.pdf
US FDA Marketing Approval for Reckitt Benckiser's Subutex & Suboxone
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