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Naloxone Switch NDA Submitted As US FDA Signals Nonprescription Access Looks Safe, Effective

 
• By Malcolm Spicer

Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.

• Source: Shutterstock

Some questions the US Food and Drug Administration announced on 15 November about safe and effective use of naloxone as a nonprescription product could be answered in a new drug application submitted three weeks earlier.

Harm Reduction Therapeutics Inc. on 28 October submitted to the FDA its NDA for OTC approval of a 3-mg intranasal naloxone product branded RiVive

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