FDA Denies Reckitt Petition Over Generic Suboxone

WE ARE REPEATING THIS FROM THE WEEKEND: In a huge blow to Reckitt Benckiser, the FDA late last week rejected a citizen petition the company had filed last fall in hopes of thwarting generic rivals to its best-selling Suboxone tablet for treating opioid dependence. Moreover, the agency also referred the issue to the US Federal Trade Commission in response to comments filed by generic drug makers that Reckitt had engaged in anticompetitive business practices. The decision, which was accompanied by FDA approval of two generic versions, caps a long-running controversy over the Reckitt strategy to maintain its Suboxone franchise. The drugmaker, which is based in the UK and best known for household cleaning products, has used various tactics to convince the FDA that lower-cost generic versions could raise safety issues for children, while bolstering sales of a newer product with a longer patent life. Since 2010, Reckitt has aggressively promoted its new sublingual Suboxone Film, a newer version of its drug that dissolves under the tongue and can only be accessed by tearing open individual blister packaging. The patent on Suboxone tablets expired three years ago, while the patent on Suboxone Film expires in 2022. And Reckitt has gradually raised the price of Suboxone Tablets in order to switch patients to the newer version (back story). Meanwhile, Reckitt asked the FDA not to approve generics unless the risk of accidental pediatric exposure was addressed and child-resistant, unit-d...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Actavis Amneal Pharmaceuticals FDA Opioid Dependance Reckitt Benckiser Suboxone Source Type: blogs