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Harm Reduction Therapeutics Inc. doesn’t have to make an advisory committee presentation for its proposal for an OTC naloxone nasal spray, but still must wait for a US Food and Drug Administration decision it’s confident will be for approval. The FDA on 1 March announced it cancelled the meeting of its Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory committees to consider HRT’s new drug application for a 3-mg naloxone nasal spray scheduled 20 March. “The meeting is no longer needed,” the agency states in the announcement scheduled for publication in the Federal Register on 2 March.

Harm Reduction Therapeutics Inc. doesn’t have to make an advisory committee presentation for its proposal for an OTC naloxone nasal spray, but still must wait for a US Food and Drug Administration decision it’s confident will be for approval. The FDA on 1 March announced it cancelled the meeting of its Nonprescription Drug and Anesthetic and Analgesic Drug Products advisory committees to consider HRT’s new drug application for a 3-mg naloxone nasal spray scheduled 20 March. “The meeting is no longer needed,” the agency states in the announcement scheduled for publication in the Federal Register on 2 March.

by Philip Kantor | Mar 2, 2023 | News

Drug companies could have made naloxone more accessible. Why didn’t they?

https://www.washingtonpost.com/opinions/2023/01/23/naloxone-over-the-counter-opioid-overdose-antidote/#new_tab
FDA Fast-Tracks Review of Overdose Drug Naloxone for Use Without Prescription

FDA Fast-Tracks Review of Overdose Drug Naloxone for Use Without Prescription

by Philip Kantor | Jan 3, 2023 | News

   
New Drug Application for RiVive™ Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA

New Drug Application for RiVive™ Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA

by Philip Kantor | Jan 3, 2023 | News

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

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

by Brian Shim | Nov 2, 2022 | News

New Drug Application for RiVive™ Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA

OTC Naloxone One Step Closer as Harm Reduction Therapeutics Initiates a Rolling Submission of its New Drug Application to U.S. FDA for RiVive™ for Emergency Treatment of Opioid Overdose

by Brian Shim | Oct 11, 2022 | News

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About

Harm Reduction Therapeutics (HRT), Inc. is a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making free or low-cost over-the-counter naloxone available to everyone. Founded in 2017 in response to the severe price and access limits to existing naloxone products, HRT brings together experts in drug development, harm reduction, substance dependence, public health policy, and over-the-counter switches of prescription pharmaceuticals.

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