FDA Decision on Citizen's Petition-Generics Approval

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

PR Newswire

London, February 24

25 February 2013

FDA Response to Citizen's Petition and Announcement of Generics Approval

Reckitt Benckiser (RB) notes that the US Food and Drug Administration (FDA) hasdenied a Citizen's Petition filed by the RB Pharmaceuticals business (RBP). Inthe Citizen's Petition, RBP presented a new evaluation of paediatric exposuredata and recommended that the FDA adopt more stringent packaging standards andincreased educational interventions to help reduce the number of childrenexposed to buprenorphine-containing products used to treat opioid dependence.The FDA concluded that the safety data presented by RB Pharmaceuticals did notwarrant these additional measures, deciding instead that existing labelling andsafety programmes were sufficient.

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

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

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

Please see full Prescribing Information at:

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