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Reckitt Benckiser Gp (RB.)

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Monday 25 February, 2013

Reckitt Benckiser Gp

FDA Decision on Citizen's Petition-Generics App...


                                                                               
25 February 2013

                Reckitt Benckiser Pharmaceuticals Inc. Receives                
   FDA Response to Citizen's Petition and Announcement of Generics Approval    

Reckitt Benckiser (RB) notes that the US Food and Drug Administration (FDA) has
denied a Citizen's Petition filed by the RB Pharmaceuticals business (RBP). In
the Citizen's Petition, RBP presented a new evaluation of paediatric exposure
data and recommended that the FDA adopt more stringent packaging standards and
increased educational interventions to help reduce the number of children
exposed to buprenorphine-containing products used to treat opioid dependence.
The FDA concluded that the safety data presented by RB Pharmaceuticals did not
warrant these additional measures, deciding instead that existing labelling and
safety programmes were sufficient.

RBP is disappointed with the decision but will continue to work with the FDA on
safety enhancements. RBP remains committed to maintaining its own high level
standards for safety, including the use of child resistant, unit-dose packaging
for its buprenorphine-based opioid dependence treatment products. It will
therefore carry on with the decision to discontinue the sale of its loose
tablet bottles of SUBOXONE in the United States in favour of other effective
treatment options that have shown reduced paediatric exposure rates.

In the communication from the FDA, RBP was also informed that two unnamed
manufacturers have now received approval to produce generic SUBOXONE Tablets
buprenorphine and naloxone) Sublingual (CIII) in the US. The details of these
manufacturers' proposed safety programmes have not been provided.

RBP is a pioneer in the development of innovative prescription treatments for
the chronic diseases of addiction and introduced SUBOXONE Film (buprenorphine
and naloxone) Sublingual (CIII) in 2010 as a next generation product with
enhanced features, including unit-dose, child resistant packaging. This was in
response to patient and provider feedback and reports of misuse, abuse,
diversion and pediatric exposure associated with the buprenorphine and naloxone
tablets. RBP remains confident in the value and benefits of SUBOXONE Film as
the product is a significant advancement in product technology.

Please see full Prescribing Information at:

http://www.suboxone.com/pdfs/SuboxonePI.pdf.

                                   - ENDS -                                    

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