FDA approves new product labelling for OxyContin Controlled Release(Purdue Pharma) for Pain Management

Purdue Pharma L.P. has announced that the FDA has approved new language for the product label for OxyContin (oxycodone hydrochloride controlled-release) Tablets CII that describes abuse-deterrence studies conducted with the reformulated tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting). The tablet is more difficult to crush, break, or dissolve. It also forms a viscous hydrogel and cannot be easily prepared for injection.

Additionally, Purdue is gratified that the FDA has determined that the original OxyContin extended release tablets were withdrawn from sale for reasons of safety or effectiveness. FDA will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.