Opioid Compounding Restrictions Could Create New Headaches For FDA
Advisory committee votes to add oxycodone to do-not-compound list, but will compounders now begin producing abuse-deterrent formulations?
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ANDAs mistakenly still are cataloged as approved even though they have been withdrawn from marketing.
There will be no generics of original OxyContin; FDA says it can no longer serve as a reference product because it has a greater abuse potential than the reformulation, where Purdue has secured particularly strong language regarding reducing intranasal abuse.
Purdue epidemiological studies indicate reformulation of OxyContin had a positive effect on abuse and misuse of the drug, but the company says continued monitoring is needed to assess whether the positive trend continues.