In pharmacy news:

Purdue pulled its New Drug Application (NDA) with the FDA for the abuse-deterrent formulation of OxyContin. Citing a need for additional analyses of data on the product, the company formally withdrew the NDA one day before agency staff would have released their evaluation of the application, prior to an advisory committee meeting scheduled for next week. The meeting was set to discuss “postmarketing studies evaluating the misuse and/or abuse of reformulated OxyContin” and whether those studies “have demonstrated that the reformulated product has a meaningful impact on abuse.” Confusion between a 2010 approval letter and a 2013 approval of abuse-deterrent labeling has raised questions about whether or not the FDA required Purdue to perform post-marketing studies of the drug’s effectiveness in reducing abuse.

Read full coverage of this story from MedPage Today here.

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