The Food and Drug Administration (FDA) has given the green light for two drug manufacturers to produce a generic version of Reckitt Benckiser's SUBOXONE tablets in the US, dealing a big blow to the consumer products giant.
Reckitt announced on Monday morning that two unnamed manufacturers had received approval to make the drug, which is used in the treatment for the chronic diseases of addiction.
The new comes after RB Pharmaceuticals business (RBP) had filed a 'Citizen's Petition' to the FDA which called for more stringent packaging standards and increased educational interventions to help lower the number of children exposed to products that contain buprenorphine - found in RBP's SUBOXONE tablets - which are used to treat opioid dependence.
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"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," Reckitt said.
The company said that it 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."
Reckitt makes a wide range of household cleaning products such as Cillit Bang and Calgon, but is also responsible for brands such as Nurofen and Strepsils.
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