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Nonprofit Pharma Targets Making Naloxone Available OTC, Trimming Price

Executive Summary

Nonprofit Harm Reduction Therapeutics targets an OTC switch of naloxone, an opioid antagonist used to reverse an opioid overdose. It aims to make the product available at low cost in 110,000 retail locations nationwide.

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US FDA Has Model Drug Facts Labels For OTC Naloxone, Needs Switch Proposals

Development of the model DFLs was a first for agency. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue

Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.

Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue

Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.

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