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Not Another Opana: US FDA Panel Rejects PTI’s Remoxy On Intravenous Abuse Concerns

Executive Summary

Studies showing oxycodone could be extracted for intravenous use troubled advisory committee members, who worried it would result in the same types of adverse public health effects that led to market withdrawal of Endo’s Opana ER; panelists also were concerned about the ability to partially defeat Remoxy’s extended-release properties by chewing the product.

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