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

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

by Philip Kantor | Jan 3, 2023 | News

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

by Brian Shim | Nov 2, 2022 | News

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