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Off-Label Opioid Promotion: US FDA ‘Does Not Object’ To Intranasal Deterrence Data, Egalet Says

Executive Summary

In decision that reflects policy confluence of opioid abuse deterrence, off-label communications and marketing exclusivity, FDA will allow Egalet to distribute truthful, nonmisleading information about Arymo ER's intranasal abuse-deterrence data even though the long-acting opioid was blocked from receiving a labeling claim.

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