FDA Response To Reckitt Benckiser Pharmaceuticals Citizen Petition Regarding Child-Safe Buprenorphine Packaging

February 22, 2013
This letter from the U.S. Food and Drug Administration (FDA) addresses a citizens petition filed in September 2012 by Reckitt Benckiser asking the FDA to require all manufacturers of buprenorphine-containing products for treating opioid dependence to implement child resistant, unit-dosed packaging to reduce the risk of pediatric exposure. Reckitt Benckiser markets a branded medication, Suboxone that previously has had no generic competition. The FDA denied the company's request.
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