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 FDA says no to RB for more stringent packaging requirements

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nannamom
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PostSubject: FDA says no to RB for more stringent packaging requirements   Mon 25 Feb 2013, 1:11 pm

One of our newest members here on our forum mentioned in a post that the FDA had denied the citizen's Petition filed by from the makers of Suboxone "Reckitt Benckiser"


RB has recommended the FDA adopt more stringent packaging standards and increased educational interventions to help reduce the number of children exposed to Buprenorphine containing products. The FDA has decided that the already existing labeling and safety programs in place are sufficient.

In other words, the FDA has decided that it is not necessary to require companies who make the Buprenorphine/naloxone combination drugs change their current packaging. If you will remember, when RB first came out with the strip formulation of Suboxone it was said to be because it was safer for households with children. Having the strips in foil type packaging was to cut down on accidental exposure/overdoses by children- The strips were harder to get into than the original tablets being placed in bottles like other prescription medications.

How did this come about?
Recently two companies were given the approval for their production of a generic Suboxone (Buprenorphine/Naloxone) "tablets"


A lot of people are asking the question, "Is RB really concerned about safety or is it the money involved"? I don't know about you but in my opinion if the makers of Suboxone were really that concerned about safety why didn't they pull all of the tablets off the shelf when they stopped making it? Why wait? Posted below is a copy of the letter sent to RB by the FDA. It is a PDF file so you may have to download it to read it.

Please see follow up articles for the approval of the new generic buprenorphine/naloxone combination.
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