FDA Updates OxyContin Label, Blocks Generic Versions — Physician’s First Watch
FDA Updates OxyContin Label, Blocks Generic Versions
By Amy Orciari Herman
The reformulated version of OxyContin, approved in 2010, will receive a label update to note its abuse-deterrent properties, the FDA announced late Tuesday. In addition, the agency said it will not approve generic versions of the original OxyContin.
The reformulated drug's physical and chemical properties should make it harder to inject or snort, according to the FDA. For example, the new tablet is difficult to crush and also forms a viscous gel that cannot easily be injected.
The agency also noted that it will not approve generic versions of the original OxyContin because the product's potential for abuse means its benefits "no longer outweigh its risks." The original OxyContin was pulled from the shelves in 2010.