Reckitt Benckiser (RB) Monday said, the U.S Food and Drug Administration, or FDA has denied a citizen's petition, regarding a new evaluation of paediatric exposure data, filed by the RB Pharmaceuticals business.
The petition recommended FDA to 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.
However, FDA said that existing labelling and safety programmes were sufficient and concluded that the safety data presented by RB Pharmaceuticals did not
warrant these additional measures.
Subsequently, the company has decided to discontinue the sale of its loose tablet bottles of SUBOXONE in the U.S in favour of other effective treatment options that have shown reduced paediatric exposure rates.
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