By Pat Anson, Editor
The Food and Drug Administration late today approved new labeling for the painkiller OxyContin that allows Purdue Pharma to maintain its monopoly on the drug by blocking generic versions from entering the market.
The new labeling states that a reformulated version of OxyContin makes the pills harder to crush or dissolve and reduces chances of abuse. Purdue Pharma began selling the tamper resistant version in 2010, replacing the original formulation of OxyContin.
“Because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin,” the FDA said in a statement.
Read more at National Pain Report.
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