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.

About RBP
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.