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Naloxone Switch: Door Opener For Other NDAs That Swing On Consumer Education

This article was originally published in The Pink Sheet Daily

Executive Summary

Health care professionals provide naloxone in an outpatient setting in “highly successful programs,” but FDA approval of a switch rests on whether “just putting the drug on the store shelf for anyone to purchase with no training or guidance on use” will be safe, says nonprescription drug division head Theresa Michele.

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