RECKITT BENCKISER GROUP PLC: FDA Decision on Citizen's Petition-Generics Approval

RECKITT BENCKISER GROUP PLC: FDA Decision on Citizen's Petition-Generics 
Approval
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 -                                     
For questions please contact: 
Investors & Analyst Queries                      +44 (0)1753 217800           
                                                                         
Richard Joyce                                                                 
                                                                         
Director, Investor Relations                                                  
                                                                         
UK Media Queries                                 +44 (0)1753 217800           
                                                                         
Andraea Dawson-Shepherd                                                       
                                             +44 (0)20 7404 5959         
SVP, Global Corporate Communication and Affairs                               
                                                                         
David Litterick / Max McGahan                                                 
                                                                         
Brunswick Financial PR                                                        
                                                                         
USA Medical Media Queries                        +1 (0) 804 594 0836          
                                                                         
Reckitt Benckiser Pharmaceutical Media Contacts  RBPMediaContacts@            
                                             reckittbenckiser.com        
USA Patient or Doctor Queries                                                 
                                             +1 (0) 866 973 4373         
For Patient Queries                                                           
                                             +1 (0) 877 782 6966         
For Doctor Queries                                                            
END 
-0- Feb/25/2013 07:00 GMT
 
 
Press spacebar to pause and continue. Press esc to stop.